The short version
15 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and Acetaminophen · ACETAMINOPHEN 325 mg/1; HYDROCODONE BITARTRATE 10 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC 63304-0497-10 · 1000 TABLET in 1 BOTTLE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →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)
0.2%chance of a new FDA shortage posting for hydrocodone bitartrate and acetaminophen (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · 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
- Ohm Laboratories Inc.United Statesmanufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Opioid Analgesic REMS Shared System REMS
Regulatory
- Application
- ANDA040826
- TE code
- —
- Approval date
- Aug 16, 2007
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Hydrocodone Bitartrate and Acetaminophen (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Asclemed USA, Inc. | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Asclemed USA, Inc. | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| NuCare Pharmaceuticals,Inc. | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| NuCare Pharmaceuticals,Inc. | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| NuCare Pharmaceuticals,Inc. | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Proficient Rx LP | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| SpecGx LLC | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| St. Mary's Medical Park Pharmacy | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| XLCare Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| XLCare Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| XLCare Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| XLCare Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 2.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| A-S Medication Solutions | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| American Health Packaging | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| American Health Packaging | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| American Health Packaging | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals of New York LLC | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals of New York LLC | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| AvPAK | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| AvPAK | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| AvPAK | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 2.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Cranbury Pharmaceuticals, LLC | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Cranbury Pharmaceuticals, LLC | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Hydrocodone Bitartrate and Acetaminophen — NDC 63304-0497-10," retrieved September 3, 2026, https://drugdashboards.com/drug/63304049710.
Free to cite with attribution — see how the data is put together.