Home NDC 75921-881 Hydrocodone Bitartrate And Acetaminophen
Product NDC 75921-881
11-digit product format 759210881
Labeler code 75921
Product ID 75921-881_b653e3b2-984b-49d7-ae0f-7f120f5d9831
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate And Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Life Line Home Care Services, Inc.
Application ANDA089971
Marketing category ANDA
Marketing start 1988-12-02
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 CIII
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 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 75921-881-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 75921-881-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 75921-881-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 75921-881-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 75921-881-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 75921-881-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 75921-881-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 75921-881-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 75921-881-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 75921-881-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 75921-881-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 75921-881-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 75921-881-30 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG TABLET / ORAL 1988-12-02
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 2 · 43 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 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089971-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500MG;5MG TABLET / ORAL 1988-12-02 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 75921-881-30 Hydrocodone Bitartrate And Acetaminophen 30 in 1 BOTTLE TABLET 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75921-881 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.] 1 Legacy NDC, 1 package rows 20120215_4bbf4358-e149-4b21-ab3a-b0c17cc43afc.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 75921-881-30 75921088130 30 in 1 BOTTLE Historical