FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
53746-109
11-digit product format
537460109
Labeler code
53746
Product ID
53746-109_a83ec256-95c3-4b3a-b911-2eb415308a4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
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

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
62be4147-6a72-49e5-9338-10887c65a93aAvailable on FDA.report

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, Related label table
NDCEffectiveRelated label
53746-109-012021-02-17Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
53746-109-052021-02-17Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
53746-109-102021-02-17Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
53746-109-012021-01-29Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
53746-109-052021-01-29Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
53746-109-102021-01-29Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-109-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10050
53746-109-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50050
53746-109-10Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-109-01EA - Each53746-10967c2ce41-740d-47ed-b425-ac22bff7937112012-07-24
53746-109-05EA - Each53746-1098267e94c-71e4-423d-866d-e3c0f8ccc39512012-07-24
53746-109-10EA - Each53746-1091a293ff6-cf55-4331-b03b-fd703d62d2c212012-07-24

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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]5
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]5
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]5
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE TABLET [DIRECT RX]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
CrospovidoneINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
PovidonesINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-109HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]48Current NDC, Legacy NDC, 3 package rows20240215_62be4147-6a72-49e5-9338-10887c65a93a.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
ndc (product): 53746-109
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 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
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN62be4147-6a72-49e5-9338-10887c65a93a50
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD62be4147-6a72-49e5-9338-10887c65a93a50
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY62be4147-6a72-49e5-9338-10887c65a93a50
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNfa2a09a8-7835-4261-a9b1-b35adab27de710
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN6b0f991d-557a-4653-bebb-68bd8057bbca10
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDfa2a09a8-7835-4261-a9b1-b35adab27de710
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD6b0f991d-557a-4653-bebb-68bd8057bbca10
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYfa2a09a8-7835-4261-a9b1-b35adab27de710
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY6b0f991d-557a-4653-bebb-68bd8057bbca10
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN5174bd9a-b777-a6e3-f72f-c16082ee67d38
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD5174bd9a-b777-a6e3-f72f-c16082ee67d38
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN41998448-c34b-3bcb-e054-00144ff88e887
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD41998448-c34b-3bcb-e054-00144ff88e887
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY41998448-c34b-3bcb-e054-00144ff88e887
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN50be5d00-758e-4d01-8e78-40a60dbe67e56
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD50be5d00-758e-4d01-8e78-40a60dbe67e56
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY50be5d00-758e-4d01-8e78-40a60dbe67e56
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 TabletPSN8e5b9848-283b-5fbf-e053-2a95a90ad5a14
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e5b9848-283b-5fbf-e053-2a95a90ad5a14
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e5b9848-283b-5fbf-e053-2a95a90ad5a14
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN2a57d570-1c0b-0426-e054-00144ff8d46c1
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNb935625d-e9e6-4b5b-a40a-3f4e7f01fa451
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2a57d570-1c0b-0426-e054-00144ff8d46c1
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDb935625d-e9e6-4b5b-a40a-3f4e7f01fa451
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY2a57d570-1c0b-0426-e054-00144ff8d46c1
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYb935625d-e9e6-4b5b-a40a-3f4e7f01fa451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-109-0153746010901100 TABLET in 1 BOTTLE (53746-109-01) 100 tablet2010-01-180000-00-00NoNoCurrent
53746-109-0553746010905500 TABLET in 1 BOTTLE (53746-109-05) 500 tablet2010-01-180000-00-00NoNoCurrent
53746-109-10537460109101000 TABLET in 1 BOTTLE (53746-109-10) 1000 tablet2010-01-180000-00-00NoNoCurrent