FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
67296-1574
11-digit product format
672961574
Labeler code
67296
Product ID
67296-1574_d61f62cf-5da9-4580-e053-2a95a90ac6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA202214
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
67296-1574-02024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-12024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-22024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-32024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-42024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-52024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-62024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-72024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-82024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap
67296-1574-92024-01-30C16284748780-11030e365-02df-111a-e063-dadaa90a10e2hydro/apap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1574-0Hydrocodone Bitartrate and Acetaminophen4 in 1 BOTTLETABLET45
67296-1574-1Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET105
67296-1574-2Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET205
67296-1574-3Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET305
67296-1574-4Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET405
67296-1574-5Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET505
67296-1574-6Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET605
67296-1574-7Hydrocodone Bitartrate and Acetaminophen6 in 1 BOTTLETABLET65
67296-1574-8Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET155
67296-1574-9Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1574HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]5Legacy NDC, 10 package rows20220123_68699eda-a72a-6b20-e053-2991aa0a89b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN68699eda-a72a-6b20-e053-2991aa0a89b55
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD68699eda-a72a-6b20-e053-2991aa0a89b55
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY68699eda-a72a-6b20-e053-2991aa0a89b55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1574-0672961574004 TABLET in 1 BOTTLE (67296-1574-0) 4 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-16729615740110 TABLET in 1 BOTTLE (67296-1574-1) 10 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-26729615740220 TABLET in 1 BOTTLE (67296-1574-2) 20 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-36729615740330 TABLET in 1 BOTTLE (67296-1574-3) 30 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-46729615740440 TABLET in 1 BOTTLE (67296-1574-4) 40 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-56729615740550 TABLET in 1 BOTTLE (67296-1574-5) 50 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-66729615740660 TABLET in 1 BOTTLE (67296-1574-6) 60 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-7672961574076 TABLET in 1 BOTTLE (67296-1574-7) 6 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-86729615740815 TABLET in 1 BOTTLE (67296-1574-8) 15 tablet2018-01-010000-00-00NoNoCurrent
67296-1574-96729615740912 TABLET in 1 BOTTLE (67296-1574-9) 12 tablet2018-01-010000-00-00NoNoCurrent