Home NDC 50436-3913 Oxycodone and Acetaminophen
Product NDC 50436-3913
11-digit product format 504363913
Labeler code 50436
Product ID 50436-3913_0d06ed8f-ecbd-4ac9-835b-b35cf31a10fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Unit Dose Services
Application ANDA201447
Marketing category ANDA
Marketing start 2013-12-10
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 5 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50436-3913-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50436-3913-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50436-3913-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50436-3913-5 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50436-3913-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50436-3913-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50436-3913-3 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50436-3913-5 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50436-3913-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50436-3913-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50436-3913-3 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50436-3913-5 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50436-3913-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50436-3913-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50436-3913-3 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50436-3913-5 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50436-3913-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50436-3913-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50436-3913-3 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50436-3913-5 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50436-3913-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50436-3913-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50436-3913-3 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50436-3913-5 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50436-3913-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50436-3913-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50436-3913-3 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50436-3913-5 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50436-3913-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50436-3913-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50436-3913-3 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50436-3913-5 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50436-3913-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50436-3913-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50436-3913-3 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50436-3913-5 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50436-3913-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50436-3913-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50436-3913-3 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50436-3913-5 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50436-3913-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50436-3913-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50436-3913-3 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50436-3913-5 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50436-3913-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50436-3913-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50436-3913-3 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50436-3913-5 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201447-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET / ORAL AA 2013-04-12 A201447-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL AA 2013-04-12 A201447-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2013-04-12 A201447-004 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2013-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-3913-1 Oxycodone and Acetaminophen 30 in 1 BOTTLE TABLET 30 17 50436-3913-2 Oxycodone and Acetaminophen 60 in 1 BOTTLE TABLET 60 17 50436-3913-3 Oxycodone and Acetaminophen 90 in 1 BOTTLE TABLET 90 17 50436-3913-5 Oxycodone and Acetaminophen 24 in 1 BOTTLE TABLET 24 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-3913 OXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES] 17 Legacy NDC, 4 package rows 20190509_8f84a572-a5a9-4c7b-adc5-ad209393befa.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-3913-1 50436391301 30 in 1 BOTTLE Historical 50436-3913-2 50436391302 60 in 1 BOTTLE Historical 50436-3913-3 50436391303 90 in 1 BOTTLE Historical 50436-3913-5 50436391305 24 in 1 BOTTLE Historical