FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-5422
11-digit product format
636295422
Labeler code
63629
Product ID
63629-5422_1960bda9-b48f-4f7a-949a-b9fb8ab1ed67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040736
Marketing category
ANDA
Marketing start
2010-01-18
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 3 · 141 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5422-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5422-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5422-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5422-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5422-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5422-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5422-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5422-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5422-9302b2466d912…e7b80fea0513…

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

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
A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2006-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040736-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040736-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2006-08-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040736-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040736-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040736-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040736-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040736-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040736-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040736-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040736-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040736-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040736-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040736-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040736-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040736-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040736-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040736-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040736-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040736-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040736-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040736-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040736-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040736-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040736-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040736-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040736-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040736-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040736-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040736-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040736-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040736-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040736-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040736-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040736-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040736-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040736-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040736-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040736-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040736-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040736-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040736-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040736-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE5 mg/1
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NO70W886KKInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857002Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a200d099-fa55-4ef1-b8d7-936a7da1db00Available on FDA.report

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, Related label table
NDCEffectiveRelated label
63629-5422-12020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-22020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-32020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-42020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-52020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-62020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-72020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-82020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-92020-10-28Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-12020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-22020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-32020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-42020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-52020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-62020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-72020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-82020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-92020-01-31Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5422-0Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET101008
63629-5422-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET301008
63629-5422-2Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1201008
63629-5422-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET201008
63629-5422-4Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET601008
63629-5422-5Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET901008
63629-5422-6Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET501008
63629-5422-7Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET401008
63629-5422-8Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET151008
63629-5422-9Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLETABLET841008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5422-0EA - Each63629-5422c89d9082-333a-40d3-af9e-3df165d4824f12025-10-14
63629-5422-1EA - Each63629-542297268d02-08fd-4c46-a8f6-535a6586c93512015-10-02
63629-5422-2EA - Each63629-542212c1ff80-9ce2-4556-8861-3ea591d8c1bf12015-10-02
63629-5422-3EA - Each63629-5422d1e5ee23-7416-4227-b349-025b58abbce112016-05-16
63629-5422-4EA - Each63629-5422a9873c7d-fb95-49cc-aae4-b82fd0bd572512016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLC62be4147-6a72-49e5-9338-10887c65a93a2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040736
application number: ANDA040736
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK5174bd9a-b777-a6e3-f72f-c16082ee67d32025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040736
application number: ANDA040736
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka200d099-fa55-4ef1-b8d7-936a7da1db002025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040736
application number: ANDA040736
ndc (product): 63629-5422
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP50be5d00-758e-4d01-8e78-40a60dbe67e52021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040736
application number: ANDA040736

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNa200d099-fa55-4ef1-b8d7-936a7da1db001008
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDa200d099-fa55-4ef1-b8d7-936a7da1db001008
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYa200d099-fa55-4ef1-b8d7-936a7da1db001008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5422-06362954220010 TABLET in 1 BOTTLE (63629-5422-0) 10 tablet2017-07-250000-00-00NoNoCurrent
63629-5422-16362954220130 TABLET in 1 BOTTLE (63629-5422-1) 30 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-263629542202120 TABLET in 1 BOTTLE (63629-5422-2) 120 tablet2014-10-140000-00-00NoNoCurrent
63629-5422-36362954220320 TABLET in 1 BOTTLE (63629-5422-3) 20 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-46362954220460 TABLET in 1 BOTTLE (63629-5422-4) 60 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-56362954220590 TABLET in 1 BOTTLE (63629-5422-5) 90 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-66362954220650 TABLET in 1 BOTTLE (63629-5422-6) 50 tablet2019-12-220000-00-00NoNoCurrent
63629-5422-76362954220740 TABLET in 1 BOTTLE (63629-5422-7) 40 tablet2014-10-230000-00-00NoNoCurrent
63629-5422-86362954220815 TABLET in 1 BOTTLE (63629-5422-8) 15 tablet2014-11-030000-00-00NoNoCurrent
63629-5422-96362954220984 TABLET in 1 BOTTLE (63629-5422-9) 84 tablet2014-12-010000-00-00NoNoCurrent