FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
12634-260
11-digit product format
126340260
Labeler code
12634
Product ID
12634-260_34f02e3f-cc77-53e4-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA090118
Marketing category
ANDA
Marketing start
2009-03-30
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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
12634-260-002021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-402021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-502021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-552021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-662021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-712021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-792021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-802021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-852021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-912021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-942021-01-29C16284748780-1ba0f9c33-0d3c-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-260-00HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLETABLET1016
12634-260-40HYDROCODONE BITARTRATE AND ACETAMINOPHEN40 in 1 BOTTLETABLET4016
12634-260-50HYDROCODONE BITARTRATE AND ACETAMINOPHEN50 in 1 BOTTLETABLET5016
12634-260-55HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BLISTER PACKTABLET1516
12634-260-66HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BLISTER PACKTABLET616
12634-260-71HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET3016
12634-260-79HYDROCODONE BITARTRATE AND ACETAMINOPHEN25 in 1 BOTTLETABLET2516
12634-260-80HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET2016
12634-260-85HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BOTTLETABLET1516
12634-260-91HYDROCODONE BITARTRATE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET116
12634-260-94HYDROCODONE BITARTRATE AND ACETAMINOPHEN4 in 1 BOTTLETABLET416

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-260HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA INC.]16Legacy NDC, 11 package rows20160610_fe743045-6501-4d99-ae8d-7b0f3e27c656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNfe743045-6501-4d99-ae8d-7b0f3e27c65616
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDfe743045-6501-4d99-ae8d-7b0f3e27c65616
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYfe743045-6501-4d99-ae8d-7b0f3e27c65616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-260-001263402600010 in 1 BOTTLEHistorical
12634-260-401263402604040 in 1 BOTTLEHistorical
12634-260-501263402605050 in 1 BOTTLEHistorical
12634-260-551263402605515 in 1 BLISTER PACKHistorical
12634-260-66126340260666 in 1 BLISTER PACKHistorical
12634-260-711263402607130 in 1 BOTTLEHistorical
12634-260-791263402607925 in 1 BOTTLEHistorical
12634-260-801263402608020 in 1 BOTTLEHistorical
12634-260-851263402608515 in 1 BOTTLEHistorical
12634-260-91126340260911 in 1 BLISTER PACKHistorical
12634-260-94126340260944 in 1 BOTTLEHistorical