Isoniazid

Product NDC
10544-087
11-digit product format
105440087
Labeler code
10544
Product ID
10544-087_1169212a-8193-5337-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA087425
Marketing category
ANDA
Marketing start
2012-09-14
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
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
0c158ae5-31fa-5bc4-3cf2-0aa120f1417dProduct name120140508
26abd97e-907b-0cb8-84ee-99fb15297adaProduct name120140508
7cf7f62d-3767-728f-c117-96e96c1ed8bfProduct name120140508
9e3dea0d-7fd5-1a7e-e095-3b9e72f40538Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-087-352020-01-31C16284748780-19d75b9cf-f053-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-087-35Isoniazid35 in 1 BOTTLETABLET351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-087ISONIAZID TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150316_1169212a-8192-5337-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN1169212a-8192-5337-e054-00144ff88e881
197832isoniazid 300 MG Oral TabletSCD1169212a-8192-5337-e054-00144ff88e881
197832INH 300 MG Oral TabletSY1169212a-8192-5337-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-087-351054400873535 in 1 BOTTLEHistorical