The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine Methylbromide · HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC 00121-1036-40 · 4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE · NDA AUTHORIZED GENERIC · 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.
Estimated fill cost
WAC per package, as filed
$512.00
Reported to Texas DSHS · 2026 annual filing · PAI Holdings LLC dba Pharmaceutical Associates, Inc. / PAI Pharma
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
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 homatropine methylbromide (other) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market · price up 8% YoY
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 →
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
- NDA005213
- TE code
- AA
- Approval date
- Jul 26, 1988
- Patents / exclusivity
- None on file
Shortage history
- Planned discontinuation — Hydromet, Syrup, 1.5 mg/5 mL; 5 mg/5 mL (NDC 0472-1030-16)Sep 11, 2025
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Hydrocodone Bitartrate and Homatropine Methylbromide (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Actavis Pharma, Inc. | HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mL | Aug 26, 2026 | Sep 2, 2026 |
| Genus Lifesciences Inc. | HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mL | Aug 26, 2026 | Sep 2, 2026 |
| PAI Holdings, LLC dba PAI Pharma | HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mL | Aug 26, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | HYDROCODONE BITARTRATE 1.5 mg/5mL; HOMATROPINE METHYLBROMIDE 5 mg/5mL | Jul 22, 2026 | Aug 19, 2026 |
| Genus Lifesciences Inc. | HYDROCODONE BITARTRATE 1.5 mg/5mL; HOMATROPINE METHYLBROMIDE 5 mg/5mL | Jul 22, 2026 | Aug 19, 2026 |
| PAI Holdings, LLC dba PAI Pharma | HYDROCODONE BITARTRATE 1.5 mg/5mL; HOMATROPINE METHYLBROMIDE 5 mg/5mL | Jul 22, 2026 | Aug 19, 2026 |
| Actavis Pharma, Inc. | HOMATROPINE METHYLBROMIDE 1.5 mg/5mL; HYDROCODONE BITARTRATE 5 mg/5mL | Jul 15, 2026 | Jul 15, 2026 |
| Genus Lifesciences Inc. | HOMATROPINE METHYLBROMIDE 1.5 mg/5mL; HYDROCODONE BITARTRATE 5 mg/5mL | Jul 15, 2026 | Jul 15, 2026 |
| PAI Holdings, LLC dba PAI Pharma | HOMATROPINE METHYLBROMIDE 1.5 mg/5mL; HYDROCODONE BITARTRATE 5 mg/5mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Hydrocodone Bitartrate and Homatropine Methylbromide — NDC 00121-1036-40," retrieved September 3, 2026, https://drugdashboards.com/drug/00121103640.
Free to cite with attribution — see how the data is put together.