The short version
4 companies supply this market — a reasonable cushion if one runs into trouble.
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/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1 · Tablet · Oral · Novel Laboratories, Inc.
NDC 40032-0118-26 · 500 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 homatropine methylbromide (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
- Novel Laboratories, Inc.United Statesanalysis · manufacture · pack
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
- ANDA091528
- TE code
- —
- Approval date
- Apr 20, 2011
- 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 Homatropine Methylbromide (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Genus Lifesciences Inc. | HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| KVK-Tech, Inc. | HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals,Inc. | HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Novel Laboratories, Inc. | HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Genus Lifesciences Inc. | HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| KVK-Tech, Inc. | HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Lupin Pharmaceuticals,Inc. | HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Novel Laboratories, Inc. | HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Genus Lifesciences Inc. | HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| KVK-Tech, Inc. | HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Lupin Pharmaceuticals,Inc. | HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Novel Laboratories, Inc. | HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1 | 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 40032-0118-26," retrieved September 3, 2026, https://drugdashboards.com/drug/40032011826.
Free to cite with attribution — see how the data is put together.