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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75921-881IInactivated by FDA2026-08-03
excluded packagepackage75921-88175921-881-30IInactivated by FDA2026-08-03

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75921-881-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75921-881-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75921-881-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage75921-881-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage75921-881-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage75921-881-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75921-881-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75921-881-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75921-881-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage75921-881-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage75921-881-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage75921-881-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage75921-881-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage75921-881-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage75921-881-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage75921-881-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage75921-881-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage75921-881-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage75921-881-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage75921-881-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage75921-881-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage75921-881-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;5MGTABLET / ORAL1988-12-02

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023f01610625f2…
2019-09-15 20:21 UTC2019-09A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
377068df-225f-7318-a910-a1987cdfa361Product name320170608
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75921-881-302019-11-13C16284748780-197449f38-cc2c-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75921-881-30Hydrocodone Bitartrate And Acetaminophen30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75921-881HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1Legacy NDC, 1 package rows20120215_4bbf4358-e149-4b21-ab3a-b0c17cc43afc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSN4bbf4358-e149-4b21-ab3a-b0c17cc43afc1
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCD4bbf4358-e149-4b21-ab3a-b0c17cc43afc1
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSY4bbf4358-e149-4b21-ab3a-b0c17cc43afc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75921-881-307592108813030 in 1 BOTTLEHistorical