FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-0108
11-digit product format
713350108
Labeler code
71335
Product ID
71335-0108_938a574e-dc14-4a18-a353-aaf96eb5bf66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201013
Marketing category
ANDA
Marketing start
2012-04-11
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 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 BITARTRATE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui857005

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0108-02024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-12024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-22024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-32024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-42024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-52024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-62024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-72024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-82024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-92024-05-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-02024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-12024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-22024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-32024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-42024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-52024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-62024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-72024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-82024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-92024-01-30C16284748780-11030e365-2eac-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0108-0Hydrocodone Bitartrate and Acetaminophen8 in 1 BOTTLETABLET88
71335-0108-1Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1208
71335-0108-2Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET158
71335-0108-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET208
71335-0108-4Hydrocodone Bitartrate and Acetaminophen28 in 1 BOTTLETABLET288
71335-0108-5Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET308
71335-0108-6Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET408
71335-0108-7Hydrocodone Bitartrate and Acetaminophen56 in 1 BOTTLETABLET568
71335-0108-8Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET608
71335-0108-9Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0108-1EA - Each71335-01086a45f044-c21f-4d3a-94e9-0077a178c04512018-09-05
71335-0108-5EA - Each71335-01083395b374-a934-4af5-b779-c98144e336ad12018-09-05
71335-0108-6EA - Each71335-0108ed7c8582-0280-4628-9602-568c7fd757e612018-06-11
71335-0108-8EA - Each71335-010831453872-6951-4ad6-9419-275ec55dbf8512018-07-03
71335-0108-9EA - Each71335-01089c417bf9-0446-4f4d-a2d3-b84a4a7c1cd712018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0108HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20241024_59a92d79-5b2d-4c10-b0ac-ea766a0ff08b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN59a92d79-5b2d-4c10-b0ac-ea766a0ff08b8
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD59a92d79-5b2d-4c10-b0ac-ea766a0ff08b8
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY59a92d79-5b2d-4c10-b0ac-ea766a0ff08b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0108-0713350108008 TABLET in 1 BOTTLE (71335-0108-0) 8 tablet2018-12-120000-00-00NoNoCurrent
71335-0108-171335010801120 TABLET in 1 BOTTLE (71335-0108-1) 120 tablet2018-06-060000-00-00NoNoCurrent
71335-0108-27133501080215 TABLET in 1 BOTTLE (71335-0108-2) 15 tablet2018-12-110000-00-00NoNoCurrent
71335-0108-37133501080320 TABLET in 1 BOTTLE (71335-0108-3) 20 tablet2018-07-090000-00-00NoNoCurrent
71335-0108-47133501080428 TABLET in 1 BOTTLE (71335-0108-4) 28 tablet2019-09-040000-00-00NoNoCurrent
71335-0108-57133501080530 TABLET in 1 BOTTLE (71335-0108-5) 30 tablet2018-06-280000-00-00NoNoCurrent
71335-0108-67133501080640 TABLET in 1 BOTTLE (71335-0108-6) 40 tablet2018-05-300000-00-00NoNoCurrent
71335-0108-77133501080756 TABLET in 1 BOTTLE (71335-0108-7) 56 tablet2024-10-080000-00-00NoNoCurrent
71335-0108-87133501080860 TABLET in 1 BOTTLE (71335-0108-8) 60 tablet2018-05-220000-00-00NoNoCurrent
71335-0108-97133501080990 TABLET in 1 BOTTLE (71335-0108-9) 90 tablet2018-05-310000-00-00NoNoCurrent