FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
12634-144
11-digit product format
126340144
Labeler code
12634
Product ID
12634-144_68fe60f5-37c3-4256-9c9d-33d3e3580a90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc.
Application
ANDA040746
Marketing category
ANDA
Marketing start
2009-03-20
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
CII
NDC exclude flag
E
Listing certified through
2018-12-31
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
12634-144-522020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-552020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-612020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-712020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-782020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-792020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-852020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII
12634-144-912020-01-31C16284748780-19d75b9d0-0da2-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-144-52Hydrocodone Bitartrate and Acetaminophen12 in 1 BLISTER PACKTABLET124
12634-144-55Hydrocodone Bitartrate and Acetaminophen15 in 1 BLISTER PACKTABLET154
12634-144-61Hydrocodone Bitartrate and Acetaminophen10 in 1 BLISTER PACKTABLET104
12634-144-71Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET304
12634-144-78Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET124
12634-144-79Hydrocodone Bitartrate and Acetaminophen25 in 1 BOTTLETABLET254
12634-144-85Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET154
12634-144-91Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-144-71EA - Each12634-144025037f1-cb34-402c-be27-16e30063e56612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-144HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4Legacy NDC, 8 package rows20141024_fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857107HYDROcodone bitartrate 10 MG / acetaminophen 500 MG Oral TabletPSNfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857383HYDROcodone bitartrate 10 MG / acetaminophen 650 MG Oral TabletPSNfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857107acetaminophen 500 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857383acetaminophen 650 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857107APAP 500 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857383APAP 650 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-144-521263401445212 in 1 BLISTER PACKHistorical
12634-144-551263401445515 in 1 BLISTER PACKHistorical
12634-144-611263401446110 in 1 BLISTER PACKHistorical
12634-144-711263401447130 in 1 BOTTLEHistorical
12634-144-781263401447812 in 1 BOTTLEHistorical
12634-144-791263401447925 in 1 BOTTLEHistorical
12634-144-851263401448515 in 1 BOTTLEHistorical
12634-144-91126340144911 in 1 BLISTER PACKHistorical