FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
45865-412
11-digit product format
458650412
Labeler code
45865
Product ID
45865-412_06640c94-07e3-42ea-ace5-2753b4295c33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA040754
Marketing category
ANDA
Marketing start
2010-02-18
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
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
45865-412-152019-11-13C16284748780-197449f38-bab9-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
45865-412-302019-11-13C16284748780-197449f38-bab9-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
45865-412-492019-11-13C16284748780-197449f38-bab9-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
45865-412-512019-11-13C16284748780-197449f38-bab9-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
45865-412-602019-11-13C16284748780-197449f38-bab9-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
45865-412-902019-11-13C16284748780-197449f38-bab9-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-412-15Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET153
45865-412-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET303
45865-412-49Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET1003
45865-412-51Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1203
45865-412-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET603
45865-412-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-412HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 6 package rows20120801_f83f57cd-0257-4745-8ee0-21dc6dc05063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857083HYDROcodone bitartrate 7.5 MG / acetaminophen 650 MG Oral TabletPSNf83f57cd-0257-4745-8ee0-21dc6dc050633
857083acetaminophen 650 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf83f57cd-0257-4745-8ee0-21dc6dc050633
857083APAP 650 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf83f57cd-0257-4745-8ee0-21dc6dc050633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-412-154586504121515 in 1 BOTTLEHistorical
45865-412-304586504123030 in 1 BOTTLEHistorical
45865-412-4945865041249100 in 1 BOTTLEHistorical
45865-412-5145865041251120 in 1 BOTTLEHistorical
45865-412-604586504126060 in 1 BOTTLEHistorical
45865-412-904586504129090 in 1 BOTTLEHistorical