Home NDC 0254-2036 Hydrocodone Bitartrate and Acetaminophen
Product NDC 0254-2036
11-digit product format 002542036
Labeler code 0254
Product ID 0254-2036_2ec6751e-3479-4bef-a1fb-42b30c837186
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA202935
Marketing category ANDA
Marketing start 2018-10-05
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength 10 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2020-12-31
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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0254-2036-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0254-2036-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0254-2036-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0254-2036-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0254-2036-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0254-2036-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0254-2036-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0254-2036-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0254-2036-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0254-2036-01 ad56d346431e…cc804d4bbf1e…
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 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL AA 2016-06-15 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL AA 2016-06-15 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET / ORAL AA 2016-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202935-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2016-06-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202935-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2016-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202935-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2016-06-15 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0254-2036-01 00254203601 100 TABLET in 1 BOTTLE (0254-2036-01) 100 tablet 2018-10-05 0000-00-00 No No Current