HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
67296-0515
11-digit product format
672960515
Labeler code
67296
Product ID
67296-0515_300e099d-aa1b-460a-8b1d-44765cfdbbac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA040655
Marketing category
ANDA
Marketing start
2006-01-19
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0515-1HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET303
67296-0515-2HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLETABLET103
67296-0515-3HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BOTTLETABLET153
67296-0515-4HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET203
67296-0515-5HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BOTTLETABLET63

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0515HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]3Legacy NDC, 5 package rows20110610_c7a9280e-e713-4773-b4bd-aabec9cff63a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNc7a9280e-e713-4773-b4bd-aabec9cff63a3
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDc7a9280e-e713-4773-b4bd-aabec9cff63a3
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYc7a9280e-e713-4773-b4bd-aabec9cff63a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0515-16729605150130 in 1 BOTTLEHistorical
67296-0515-26729605150210 in 1 BOTTLEHistorical
67296-0515-36729605150315 in 1 BOTTLEHistorical
67296-0515-46729605150420 in 1 BOTTLEHistorical
67296-0515-5672960515056 in 1 BOTTLEHistorical