FDA.reportPublic FDA data

Hydrocodone Bitartrate And Acetaminophen

Product NDC
66336-670
11-digit product format
663360670
Labeler code
66336
Product ID
66336-670_37836856-4c09-43d3-ba39-f42da6614a05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-670-062019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-102019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-122019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-202019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-242019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-302019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-402019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-502019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-602019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-902019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-670-942019-11-27C16284748780-19855d018-e4c5-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-670-06Hydrocodone Bitartrate And Acetaminophen6 in 1 BOTTLE, PLASTICTABLET64
66336-670-10Hydrocodone Bitartrate And Acetaminophen10 in 1 BOTTLE, PLASTICTABLET104
66336-670-12Hydrocodone Bitartrate And Acetaminophen12 in 1 BOTTLETABLET124
66336-670-20Hydrocodone Bitartrate And Acetaminophen20 in 1 BOTTLE, PLASTICTABLET204
66336-670-24Hydrocodone Bitartrate And Acetaminophen24 in 1 BOTTLETABLET244
66336-670-30Hydrocodone Bitartrate And Acetaminophen30 in 1 BOTTLE, PLASTICTABLET304
66336-670-40Hydrocodone Bitartrate And Acetaminophen40 in 1 BOTTLE, PLASTICTABLET404
66336-670-50Hydrocodone Bitartrate And Acetaminophen50 in 1 BOTTLE, PLASTICTABLET504
66336-670-60Hydrocodone Bitartrate And Acetaminophen60 in 1 BOTTLE, PLASTICTABLET604
66336-670-90Hydrocodone Bitartrate And Acetaminophen90 in 1 BOTTLETABLET904
66336-670-94Hydrocodone Bitartrate And Acetaminophen120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-670-10EA - Each66336-670982fecbf-472e-469d-b60f-974777f25dc312013-09-04
66336-670-24EA - Each66336-670ac99dd94-4627-41d7-9757-e33d6060e92512013-08-02
66336-670-30EA - Each66336-6706b4a737d-f4e6-4c17-9a3a-05b1da9c30e112013-09-04
66336-670-60EA - Each66336-6706932beb9-4abe-4d39-98e4-913bc4ab60fb12012-07-24
66336-670-94EA - Each66336-670a0a3f1a5-3168-460d-93d1-5598c767bb1c12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-670HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]4Legacy NDC, 11 package rows20130711_59e7db61-9ce5-416c-b576-87babe94dbdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN59e7db61-9ce5-416c-b576-87babe94dbdf4
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD59e7db61-9ce5-416c-b576-87babe94dbdf4
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY59e7db61-9ce5-416c-b576-87babe94dbdf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-670-06663360670066 in 1 BOTTLE, PLASTICHistorical
66336-670-106633606701010 in 1 BOTTLE, PLASTICHistorical
66336-670-126633606701212 in 1 BOTTLEHistorical
66336-670-206633606702020 in 1 BOTTLE, PLASTICHistorical
66336-670-246633606702424 in 1 BOTTLEHistorical
66336-670-306633606703030 in 1 BOTTLE, PLASTICHistorical
66336-670-406633606704040 in 1 BOTTLE, PLASTICHistorical
66336-670-506633606705050 in 1 BOTTLE, PLASTICHistorical
66336-670-606633606706060 in 1 BOTTLE, PLASTICHistorical
66336-670-906633606709090 in 1 BOTTLEHistorical
66336-670-9466336067094120 in 1 BOTTLEHistorical