Hydrocodone Bitartrate And Acetaminophen

Product NDC
75921-881
11-digit product format
759210881
Labeler code
75921
Product ID
75921-881_b653e3b2-984b-49d7-ae0f-7f120f5d9831
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Life Line Home Care Services, Inc.
Application
ANDA089971
Marketing category
ANDA
Marketing start
1988-12-02
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
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75921-881-302019-11-13C16284748780-197449f38-cc2c-f6ea-e053-dbdaa90aa703HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75921-881-30Hydrocodone Bitartrate And Acetaminophen30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75921-881HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1Legacy NDC, 1 package rows20120215_4bbf4358-e149-4b21-ab3a-b0c17cc43afc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSN4bbf4358-e149-4b21-ab3a-b0c17cc43afc1
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCD4bbf4358-e149-4b21-ab3a-b0c17cc43afc1
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSY4bbf4358-e149-4b21-ab3a-b0c17cc43afc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75921-881-307592108813030 in 1 BOTTLEHistorical