Hydrocodone Bitartrate And Acetaminophen

Product NDC
67046-928
11-digit product format
670460928
Labeler code
67046
Product ID
67046-928_2ebcbba3-36bb-49ec-8625-43d60fb730ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
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 productproduct67046-928IInactivated by FDA2026-08-03
excluded packagepackage67046-92867046-928-30IInactivated 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 packagepackage67046-928-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-928-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-928-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-928-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-928-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-928-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-928-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-928-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-928-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-928-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-928-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-928-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-928-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-928-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-928-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-928-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-928-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-928-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67046-928-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67046-928-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67046-928-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67046-928-30110d247fa046…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
67046-928-302019-11-13C16284748780-197449f38-c026-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-928-30Hydrocodone Bitartrate And Acetaminophen30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-928HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20120130_2ebcbba3-36bb-49ec-8625-43d60fb730ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSN2ebcbba3-36bb-49ec-8625-43d60fb730ee1
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2ebcbba3-36bb-49ec-8625-43d60fb730ee1
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSY2ebcbba3-36bb-49ec-8625-43d60fb730ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-928-306704609283030 in 1 BLISTER PACKHistorical