FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-2144
11-digit product format
713352144
Labeler code
71335
Product ID
71335-2144_2a485efe-a87c-4c55-9e17-7891b2fffb83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210211
Marketing category
ANDA
Marketing start
2018-07-13
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui857002

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
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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
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e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
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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
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96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2144-0Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET10102
71335-2144-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET30102
71335-2144-2Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET120102
71335-2144-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET20102
71335-2144-4Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET60102
71335-2144-5Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET90102
71335-2144-6Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET50102
71335-2144-7Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET40102
71335-2144-8Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET15102
71335-2144-9Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLETABLET84102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2144HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240915_2a485efe-a87c-4c55-9e17-7891b2fffb83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN2a485efe-a87c-4c55-9e17-7891b2fffb83102
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2a485efe-a87c-4c55-9e17-7891b2fffb83102
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY2a485efe-a87c-4c55-9e17-7891b2fffb83102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2144-07133521440010 TABLET in 1 BOTTLE (71335-2144-0) 10 tablet2022-08-010000-00-00NoNoCurrent
71335-2144-17133521440130 TABLET in 1 BOTTLE (71335-2144-1) 30 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-271335214402120 TABLET in 1 BOTTLE (71335-2144-2) 120 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-37133521440320 TABLET in 1 BOTTLE (71335-2144-3) 20 tablet2022-08-010000-00-00NoNoCurrent
71335-2144-47133521440460 TABLET in 1 BOTTLE (71335-2144-4) 60 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-57133521440590 TABLET in 1 BOTTLE (71335-2144-5) 90 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-67133521440650 TABLET in 1 BOTTLE (71335-2144-6) 50 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-77133521440740 TABLET in 1 BOTTLE (71335-2144-7) 40 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-87133521440815 TABLET in 1 BOTTLE (71335-2144-8) 15 tablet2024-09-060000-00-00NoNoCurrent
71335-2144-97133521440984 TABLET in 1 BOTTLE (71335-2144-9) 84 tablet2024-09-060000-00-00NoNoCurrent