HYDROCODONE BITARTATE AND ACETAMINOPHEN

Product NDC
51655-900
11-digit product format
516550900
Labeler code
51655
Product ID
51655-900_7c60a4be-adaa-edd2-e053-2991aa0a917f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA090118
Marketing category
ANDA
Marketing start
2014-05-01
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-900DDiscontinued by firm2026-10-16
excluded packagepackage51655-90051655-900-20DDiscontinued by firm2026-10-16
excluded packagepackage51655-90051655-900-30DDiscontinued by firm2026-10-16
excluded packagepackage51655-90051655-900-53DDiscontinued by firm2026-10-16
excluded packagepackage51655-90051655-900-54DDiscontinued by firm2026-10-16

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 · 80 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 packagepackage51655-900-54d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-900-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-900-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-900-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-900-54f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-900-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-900-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-900-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-900-542ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-900-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-900-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-900-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-900-54a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-900-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-900-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-900-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-900-54cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-900-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-900-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-900-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-900-54cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-900-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-900-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-900-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-900-54302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-900-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-900-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-900-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-900-54ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-900-53ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-900-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-900-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-900-540efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-900-530efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-900-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-900-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-900-54ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-900-53ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-900-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-900-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-900-54367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-900-53367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-900-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-900-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-900-54557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-900-53557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-900-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-900-20557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-23c2088c7a36db…
2026-10-15 13:18:302026-09A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-23c2088c7a36db…
2026-10-15 13:18:302026-09A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-23c2088c7a36db…
2026-09-14 22:38:342026-08A090118-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-12-2384e616aacf4f…
2026-09-14 22:38:342026-08A090118-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-12-2384e616aacf4f…
2026-09-14 22:38:342026-08A090118-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-12-2384e616aacf4f…
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…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090118-002AA13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090118-003AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090118-001AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A090118-002AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A090118-003AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090118-001AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090118-002AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090118-003AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090118-001AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090118-002AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090118-003AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090118-001AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090118-002AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090118-003AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090118-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A090118-002AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A090118-003AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090118-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090118-002AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090118-003AA1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#