FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
42254-214
11-digit product format
422540214
Labeler code
42254
Product ID
42254-214_5f215257-7c82-478f-a263-6fb37b438d69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA090118
Marketing category
ANDA
Marketing start
2009-03-30
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
42254-214-002019-09-24C16284748780-19350213a-3c3b-c013-e053-90daa90a1393Hydrocodone/Acetaminophen CIII Rx only
42254-214-202019-09-24C16284748780-19350213a-3c3b-c013-e053-90daa90a1393Hydrocodone/Acetaminophen CIII Rx only
42254-214-302019-09-24C16284748780-19350213a-3c3b-c013-e053-90daa90a1393Hydrocodone/Acetaminophen CIII Rx only
42254-214-602019-09-24C16284748780-19350213a-3c3b-c013-e053-90daa90a1393Hydrocodone/Acetaminophen CIII Rx only
42254-214-902019-09-24C16284748780-19350213a-3c3b-c013-e053-90daa90a1393Hydrocodone/Acetaminophen CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-214-00HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET1001
42254-214-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET201
42254-214-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET301
42254-214-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET601
42254-214-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-214-00EA - Each42254-214731b7172-f55c-4c1c-8d23-56441436d7bb12013-02-13
42254-214-20EA - Each42254-21451f94351-9db8-4b6b-822a-3d1abb520c8812013-02-13
42254-214-30EA - Each42254-2140aad837b-2063-4814-be55-b6b05d9b36c812013-02-13
42254-214-60EA - Each42254-21446c19e70-d855-476b-b24e-ea6b439ca38d12013-02-13
42254-214-90EA - Each42254-2142877389d-e8e0-477a-8982-d5a14cf0e1c312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-214HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 5 package rows20121129_5f215257-7c82-478f-a263-6fb37b438d69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN5f215257-7c82-478f-a263-6fb37b438d691
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD5f215257-7c82-478f-a263-6fb37b438d691
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY5f215257-7c82-478f-a263-6fb37b438d691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-214-0042254021400100 in 1 BOTTLEHistorical
42254-214-204225402142020 in 1 BOTTLEHistorical
42254-214-304225402143030 in 1 BOTTLEHistorical
42254-214-604225402146060 in 1 BOTTLEHistorical
42254-214-904225402149090 in 1 BOTTLEHistorical