Hydrocodone Bitartrate and Acetaminophen

Product NDC
67296-1377
11-digit product format
672961377
Labeler code
67296
Product ID
67296-1377_d61fb856-cf59-4500-e053-2995a90ad417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040746
Marketing category
ANDA
Marketing start
2016-06-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1377-32024-01-30C16284748780-11030e365-6d24-111a-e063-dadaa90a10e2504b4763-a992-2760-e054-00144ff8d46c
67296-1377-62024-01-30C16284748780-11030e365-6d24-111a-e063-dadaa90a10e2504b4763-a992-2760-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1377-3Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET307
67296-1377-6Hydrocodone Bitartrate and Acetaminophen6 in 1 BOTTLETABLET67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1377HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]7Legacy NDC, 2 package rows20220123_504b4763-a992-2760-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN504b4763-a992-2760-e054-00144ff8d46c7
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD504b4763-a992-2760-e054-00144ff8d46c7
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY504b4763-a992-2760-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1377-36729613770330 TABLET in 1 BOTTLE (67296-1377-3) 30 tablet2016-06-300000-00-00NoNoCurrent
67296-1377-6672961377066 TABLET in 1 BOTTLE (67296-1377-6) 6 tablet2016-06-300000-00-00NoNoCurrent