The short version
Only one company currently supplies this market — there is no backup if it stumbles.
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Hydrocodone/APAP
Hydrocodone/APAP · HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 · Tablet · Oral · Direct_Rx
NDC 72189-0650-30 · 30 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.
Where it's made
- Direct RxUnited Statesrepack
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
- ANDA210211
- TE code
- AA
- Approval date
- Oct 30, 2017
- 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/APAP (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Direct_Rx | HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Direct_Rx | HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Direct_Rx | ACETAMINOPHEN 325 mg/1; HYDROCODONE BITARTRATE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Direct_Rx | HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Direct_Rx | HYDROCODONE BITARTRATE 325 mg/1; ACETAMINOPHEN 10 mg/1 | Jul 22, 2026 | Aug 22, 2026 |
| Direct_Rx | HYDROCODONE BITARTRATE 325 mg/1; ACETAMINOPHEN 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Direct_Rx | HYDROCODONE BITARTRATE 325 mg/1; ACETAMINOPHEN 7.5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Direct_Rx | ACETAMINOPHEN 325 mg/1; HYDROCODONE BITARTRATE 10 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Direct_Rx | ACETAMINOPHEN 325 mg/1; HYDROCODONE BITARTRATE 7.5 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/APAP — NDC 72189-0650-30," retrieved September 3, 2026, https://drugdashboards.com/drug/72189065030.
Free to cite with attribution — see how the data is put together.