Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil Fumarate · EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 · Tablet, Film Coated · Aurobindo Pharma Limited
NDC 65862-0354-15 · 1500 TABLET, FILM COATED in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 61958-0701-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · manufacture
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
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- TE code
- —
- Approval date
- —
- Patents / exclusivity
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Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Emtricitabine and Tenofovir Disoproxil Fumarate (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| A-S Medication Solutions | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Aurobindo Pharma Limited | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| NuCare Pharmaceuticals, Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Patheon Inc. | EMTRICITABINE 167 mg/1; TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Patheon Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Amneal Pharmaceuticals NY LLC | EMTRICITABINE 167 mg/1; TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | EMTRICITABINE 100 mg/1; TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | EMTRICITABINE 133 mg/1; TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EMTRICITABINE 133 mg/1; TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EMTRICITABINE 167 mg/1; TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EMTRICITABINE 100 mg/1; TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| DirectRx | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Exelan Pharmaceuticals, Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Gilead Sciences, Inc | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Gilead Sciences, Inc | EMTRICITABINE 133 mg/1; TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Gilead Sciences, Inc | EMTRICITABINE 100 mg/1; TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Gilead Sciences, Inc | EMTRICITABINE 167 mg/1; TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Laurus Labs Limited | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NorthStar RxLLC | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NuCare Pharmaceuticals,Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Quallent Pharmaceuticals Health Llc | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Redpharm Drug | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rottendorf Pharma GmbH | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Takeda GmbH | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | EMTRICITABINE 100 mg/1; TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | EMTRICITABINE 167 mg/1; TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | EMTRICITABINE 133 mg/1; TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | EMTRICITABINE 167 mg/1; TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | EMTRICITABINE 133 mg/1; TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | EMTRICITABINE 100 mg/1; TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Cipla USA Inc. | EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Emtricitabine and Tenofovir Disoproxil Fumarate — NDC 65862-0354-15," retrieved September 3, 2026, https://drugdashboards.com/drug/65862035415.
Free to cite with attribution — see how the data is put together.