FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
21695-272
11-digit product format
216950272
Labeler code
21695
Product ID
21695-272_64970a9e-6ab7-410d-820f-7e2c0e4dc494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA040746
Marketing category
ANDA
Marketing start
2010-02-10
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-272-002019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-102019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-152019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-212019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-282019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-302019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-602019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-722019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
21695-272-902019-09-24C16284748780-1934fe258-4b42-48b1-e053-8cdaa90a720aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-272-00Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET1002
21695-272-10Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET102
21695-272-15Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET152
21695-272-21Hydrocodone Bitartrate and Acetaminophen21 in 1 BOTTLETABLET212
21695-272-28Hydrocodone Bitartrate and Acetaminophen28 in 1 BOTTLETABLET282
21695-272-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET302
21695-272-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET602
21695-272-72Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1202
21695-272-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-272HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 9 package rows20111227_f6d5fe9a-032f-4cea-8e75-0849878a36bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
857118HYDROcodone bitartrate 7.5 MG / acetaminophen 500 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
833036HYDROcodone bitartrate 7.5 MG / acetaminophen 750 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
857118acetaminophen 500 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
833036acetaminophen 750 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
857118APAP 500 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
833036APAP 750 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-272-0021695027200100 in 1 BOTTLEHistorical
21695-272-102169502721010 in 1 BOTTLEHistorical
21695-272-152169502721515 in 1 BOTTLEHistorical
21695-272-212169502722121 in 1 BOTTLEHistorical
21695-272-282169502722828 in 1 BOTTLEHistorical
21695-272-302169502723030 in 1 BOTTLEHistorical
21695-272-602169502726060 in 1 BOTTLEHistorical
21695-272-7221695027272120 in 1 BOTTLEHistorical
21695-272-902169502729090 in 1 BOTTLEHistorical