Hydrocodone Bitartrate and Acetaminophen

Product NDC
50090-4072
11-digit product format
500904072
Labeler code
50090
Product ID
50090-4072_9f24a216-bba3-4506-9735-fe904900819d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090118
Marketing category
ANDA
Marketing start
2016-12-14
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
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct50090-4072IInactivated by FDA2026-09-09
excluded packagepackage50090-407250090-4072-0IInactivated by FDA2026-09-09

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 · 30 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 packagepackage50090-4072-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4072-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4072-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4072-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4072-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4072-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4072-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4072-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4072-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4072-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4072-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4072-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4072-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4072-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4072-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORAL2008-12-23
A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORAL2008-12-23
A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORAL2008-12-23

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-231e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090118-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090118-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090118-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090118-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090118-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090118-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090118-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090118-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090118-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090118-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090118-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090118-003AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090118-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090118-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090118-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090118-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090118-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090118-003AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090118-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090118-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090118-003AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090118-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090118-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090118-003AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090118-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090118-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090118-003AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090118-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090118-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090118-003AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090118-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A090118-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A090118-003AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090118-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090118-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090118-003AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090118-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090118-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090118-003AA1ea99ee380514…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090118-001AA13f0d92c62455…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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
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
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4072-02023-01-30C16284748780-1f386c64a-001f-0266-e053-dadaa90a7c1aHydrocodone Bitartrate and Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4072-0Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4072HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20190607_da60f2ed-8127-4031-94c4-d616473ac07a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNda60f2ed-8127-4031-94c4-d616473ac07a3
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDda60f2ed-8127-4031-94c4-d616473ac07a3
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYda60f2ed-8127-4031-94c4-d616473ac07a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4072-05009040720020 TABLET in 1 BOTTLE (50090-4072-0) 20 tablet2019-01-180000-00-00NoNoCurrent