FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
68387-235
11-digit product format
683870235
Labeler code
68387
Product ID
68387-235_6baa87dc-cd24-4cc9-8e7d-4bf27484745a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA040746
Marketing category
ANDA
Marketing start
2010-11-17
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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
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106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-235-122019-10-29C16284748780-1960f7f55-c8e4-8e05-e053-dbdaa90a074aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
68387-235-182019-10-29C16284748780-1960f7f55-c8e4-8e05-e053-dbdaa90a074aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
68387-235-302019-10-29C16284748780-1960f7f55-c8e4-8e05-e053-dbdaa90a074aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
68387-235-402019-10-29C16284748780-1960f7f55-c8e4-8e05-e053-dbdaa90a074aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
68387-235-602019-10-29C16284748780-1960f7f55-c8e4-8e05-e053-dbdaa90a074aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
68387-235-902019-10-29C16284748780-1960f7f55-c8e4-8e05-e053-dbdaa90a074aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-235-12Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLE, PLASTICTABLET1201
68387-235-18Hydrocodone Bitartrate and Acetaminophen180 in 1 BOTTLE, PLASTICTABLET1801
68387-235-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLE, PLASTICTABLET301
68387-235-40Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLE, PLASTICTABLET401
68387-235-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLE, PLASTICTABLET601
68387-235-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-235-12EA - Each68387-2352ebe4cd3-9b03-45bc-9679-58c9ca6c863112012-07-24
68387-235-18EA - Each68387-2356da17353-91fc-4cbc-b771-6c98537644da12012-07-24
68387-235-30EA - Each68387-235864840d5-b882-4480-9cba-219fe896fb2e12012-07-24
68387-235-40EA - Each68387-23575267e1e-c43c-41c9-9e83-eb5022f2b5ab12012-07-24
68387-235-60EA - Each68387-235d614822c-6cc7-4713-94ea-76ef0937d53512012-07-24
68387-235-90EA - Each68387-2351b813e5d-0fd5-4043-ad4a-939542b51dae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-235HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 6 package rows20110107_45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb1
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb1
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-235-1268387023512120 in 1 BOTTLE, PLASTICHistorical
68387-235-1868387023518180 in 1 BOTTLE, PLASTICHistorical
68387-235-306838702353030 in 1 BOTTLE, PLASTICHistorical
68387-235-406838702354040 in 1 BOTTLE, PLASTICHistorical
68387-235-606838702356060 in 1 BOTTLE, PLASTICHistorical
68387-235-906838702359090 in 1 BOTTLE, PLASTICHistorical