FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
57664-176
11-digit product format
576640176
Labeler code
57664
Product ID
57664-176_e4d8d15c-2a44-443d-8b50-e41095925da1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090118
Marketing category
ANDA
Marketing start
2009-03-30
Marketing end
2021-08-31
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-176DDiscontinued by firm2026-09-09
excluded packagepackage57664-17657664-176-08DDiscontinued by firm2026-09-09
excluded packagepackage57664-17657664-176-13DDiscontinued by firm2026-09-09
excluded packagepackage57664-17657664-176-18DDiscontinued by firm2026-09-09
excluded packagepackage57664-17657664-176-83DDiscontinued by firm2026-09-09
excluded packagepackage57664-17657664-176-88DDiscontinued by firm2026-09-09

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 2 · 72 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 packagepackage57664-176-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-176-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-176-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-176-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-176-13d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-176-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-176-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-176-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-176-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-176-13f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-176-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-176-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-176-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-176-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-176-132ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-176-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-176-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-176-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-176-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-176-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-176-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-176-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-176-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-176-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-176-13cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-176-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-176-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-176-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-176-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-176-13cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-176-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-176-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-176-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-176-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-176-13302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-176-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-176-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-176-83ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-176-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-176-13ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-176-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-176-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-176-830efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-176-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-176-130efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-176-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-176-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-176-83ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-176-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-176-13ad56d346431e…cc804d4bbf1e…

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
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
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57664-176-082020-09-14Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-132020-09-14Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-182020-09-14Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-832020-09-14Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-882020-09-14Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-082020-07-22Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-132020-07-22Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-182020-07-22Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-832020-07-22Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
57664-176-882020-07-22Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-176-13EA - Each57664-1769d0b69cc-09b3-4ca3-a625-8fbb1d908fbf12012-07-24
57664-176-88EA - Each57664-17615199aba-961c-4fa0-987c-2ec00234687d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN4f42bbd5-9b62-3ec9-e054-00144ff8d46c4
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD4f42bbd5-9b62-3ec9-e054-00144ff8d46c4
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY4f42bbd5-9b62-3ec9-e054-00144ff8d46c4
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN5f215257-7c82-478f-a263-6fb37b438d691
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD5f215257-7c82-478f-a263-6fb37b438d691
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY5f215257-7c82-478f-a263-6fb37b438d691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-176-0857664017608100 TABLET in 1 BOTTLE (57664-176-08) 100 tablet2009-03-302021-08-31NoNoCurrent
57664-176-1357664017613500 TABLET in 1 BOTTLE (57664-176-13) 500 tablet2009-03-302021-08-31NoNoCurrent
57664-176-18576640176181000 TABLET in 1 BOTTLE (57664-176-18) 1000 tablet2009-03-302021-08-31NoNoCurrent
57664-176-835766401768330 TABLET in 1 BOTTLE (57664-176-83) 30 tablet2009-03-302021-08-31NoNoCurrent
57664-176-8857664017688100 TABLET in 1 BOTTLE (57664-176-88) 100 tablet2009-03-302021-08-31NoNoCurrent