Hydrocodone Bitartrate and Acetaminophen

Product NDC
52959-737
11-digit product format
529590737
Labeler code
52959
Product ID
52959-737_76c916a4-b168-2429-e053-2991aa0a52cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
H.J Harkins Co., Inc
Application
ANDA040736
Marketing category
ANDA
Marketing start
2017-12-11
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
2019-12-31
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 · 23 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-737IInactivated by FDA2026-09-09
excluded productproduct52959-737IInactivated by FDA2026-09-09
excluded productproduct52959-737IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-12IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-02IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-15IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-20IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-25IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-28IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-30IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-40IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-42IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-45IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-50IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-60IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-90IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-00IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-04IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-10IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-14IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-16IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-21IInactivated by FDA2026-09-09
excluded packagepackage52959-73752959-737-24IInactivated 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 9 · 498 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-737-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-737-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-737-212ef7874e63bc…57b86245f4fa…

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…

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, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
52959-737-002020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-042020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-102020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-122020-01-319d75b9d0-08c5-f424-e053-dadaa90a57ce5b4e2c4e-4e53-7794-e053-2a91aa0ab4e6
52959-737-142020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-162020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-212020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-242020-01-319d75b9d0-9025-f424-e053-dadaa90a57ce0737 HYDRO/APAP 5/325MG
52959-737-022019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-152019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-202019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-252019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-282019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-302019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-402019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-422019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-452019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-502019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-602019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-902019-12-0497449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-022019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-152019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-202019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-252019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-282019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-302019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-402019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-422019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-452019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-502019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-602019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
52959-737-902019-11-1397449f38-d0c4-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-737-02Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1205
52959-737-15Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET155
52959-737-20Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET205
52959-737-25Hydrocodone Bitartrate and Acetaminophen25 in 1 BOTTLETABLET255
52959-737-28Hydrocodone Bitartrate and Acetaminophen28 in 1 BOTTLETABLET285
52959-737-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET305
52959-737-40Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET405
52959-737-42Hydrocodone Bitartrate and Acetaminophen42 in 1 BOTTLETABLET425
52959-737-45Hydrocodone Bitartrate and Acetaminophen45 in 1 BOTTLETABLET455
52959-737-50Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET505
52959-737-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET605
52959-737-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET905
52959-737-00Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET1002
52959-737-04Hydrocodone Bitartrate and Acetaminophen4 in 1 BOTTLETABLET42
52959-737-10Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET102
52959-737-14Hydrocodone Bitartrate and Acetaminophen14 in 1 BOTTLETABLET142
52959-737-16Hydrocodone Bitartrate and Acetaminophen16 in 1 BOTTLETABLET162
52959-737-21Hydrocodone Bitartrate and Acetaminophen21 in 1 BOTTLETABLET212
52959-737-24Hydrocodone Bitartrate and Acetaminophen24 in 1 BOTTLETABLET242
52959-737-12Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-737-02EA - Each52959-7372dfec9c6-20f4-4169-80de-daee80a86bc812012-07-24
52959-737-15EA - Each52959-737aa88f877-ae55-4074-a468-3d77637f035c12012-07-24
52959-737-20EA - Each52959-737a1cbf550-6693-43a7-8ee3-20e894d445fe12012-07-24
52959-737-25EA - Each52959-737b8188df3-bd3d-4274-b569-37225cf7dcea12012-07-24
52959-737-28EA - Each52959-73711083376-a52b-41af-89aa-d6c6065f286012013-02-13
52959-737-30EA - Each52959-7378b0f3891-a3eb-4a6d-8a61-455b23b5d20812012-07-24
52959-737-40EA - Each52959-737f4c2ff8e-473b-4583-b4cc-8320fb7db33a12012-07-24
52959-737-42EA - Each52959-73732fee63b-d7de-4b9b-8112-4522ca5e7ae512013-02-13
52959-737-45EA - Each52959-7370ab9fc3f-95fa-4f12-9347-f33a35a361f612012-07-24
52959-737-50EA - Each52959-7372412f17a-3175-4471-8db2-a5d584a595d712012-07-24
52959-737-60EA - Each52959-7371c6405b9-af8f-4bff-b920-a23eaf86455c12012-07-24
52959-737-90EA - Each52959-73776f4983a-d09d-4786-b4de-dc0b6e538e3d12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-737HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]5Legacy NDC, 12 package rows20120425_221c6c53-35b8-4bd7-adfc-f8200b9f49c1.zip
52959-737HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J HARKINS CO., INC]2Legacy NDC, 7 package rows20220919_6983f612-ab66-de4f-e053-2a91aa0ac0c4.zip
52959-737HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20171012_5b4e2c4e-4e53-7794-e053-2a91aa0ab4e6.zip

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
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 TabletPSN221c6c53-35b8-4bd7-adfc-f8200b9f49c15
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD221c6c53-35b8-4bd7-adfc-f8200b9f49c15
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY221c6c53-35b8-4bd7-adfc-f8200b9f49c15
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN6983f612-ab66-de4f-e053-2a91aa0ac0c42
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD6983f612-ab66-de4f-e053-2a91aa0ac0c42
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY6983f612-ab66-de4f-e053-2a91aa0ac0c42
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN5b4e2c4e-4e53-7794-e053-2a91aa0ab4e61
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD5b4e2c4e-4e53-7794-e053-2a91aa0ab4e61
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY5b4e2c4e-4e53-7794-e053-2a91aa0ab4e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-737-0052959073700100 in 1 BOTTLEHistorical
52959-737-0252959073702120 in 1 BOTTLEHistorical
52959-737-04529590737044 in 1 BOTTLEHistorical
52959-737-105295907371010 in 1 BOTTLEHistorical
52959-737-125295907371212 in 1 BOTTLEHistorical
52959-737-145295907371414 in 1 BOTTLEHistorical
52959-737-155295907371515 in 1 BOTTLEHistorical
52959-737-165295907371616 in 1 BOTTLEHistorical
52959-737-205295907372020 in 1 BOTTLEHistorical
52959-737-215295907372121 in 1 BOTTLEHistorical
52959-737-245295907372424 in 1 BOTTLEHistorical
52959-737-255295907372525 in 1 BOTTLEHistorical
52959-737-285295907372828 in 1 BOTTLEHistorical
52959-737-305295907373030 in 1 BOTTLEHistorical
52959-737-405295907374040 in 1 BOTTLEHistorical
52959-737-425295907374242 in 1 BOTTLEHistorical
52959-737-455295907374545 in 1 BOTTLEHistorical
52959-737-505295907375050 in 1 BOTTLEHistorical
52959-737-605295907376060 in 1 BOTTLEHistorical
52959-737-905295907379090 in 1 BOTTLEHistorical