Home NDC 50090-2772 Hydrocodone Bitartrate and Acetaminophen
Product NDC 50090-2772
11-digit product format 500902772
Labeler code 50090
Product ID 50090-2772_8132908b-67fd-437f-945a-f88d1d7e53d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA090118
Marketing category ANDA
Marketing start 2014-04-01
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength 5 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL 2008-12-23 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL 2008-12-23 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET / ORAL 2008-12-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090118-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2008-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090118-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2008-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090118-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2008-12-23 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.