FDA.reportPublic FDA data

Isoniazid

Product NDC
53002-2920
11-digit product format
530022920
Labeler code
53002
Product ID
53002-2920_7f8d0976-9ab9-479f-83df-79e1b9b0617f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA080937
Marketing category
ANDA
Marketing start
1972-09-01
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-2920-02025-01-30C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-32025-01-30C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-62025-01-30C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-02023-06-08C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-32023-06-08C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-62023-06-08C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-02023-01-30C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-32023-01-30C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-62023-01-30C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-02020-12-15C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-32020-12-15C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-62020-12-15C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-02020-01-31C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-32020-01-31C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP
53002-2920-62020-01-31C16284748780-19d75b9cf-f13d-f424-e053-dadaa90a57ceIsoniazid Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2920-0Isoniazid100 in 1 BOTTLETABLET1005
53002-2920-3Isoniazid30 in 1 BOTTLETABLET305
53002-2920-6Isoniazid60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2920ISONIAZID TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20230609_d0037303-a025-4dcc-9c24-65bc2b66a010.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNd0037303-a025-4dcc-9c24-65bc2b66a0105
197832isoniazid 300 MG Oral TabletSCDd0037303-a025-4dcc-9c24-65bc2b66a0105
197832INH 300 MG Oral TabletSYd0037303-a025-4dcc-9c24-65bc2b66a0105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2920-053002292000100 TABLET in 1 BOTTLE (53002-2920-0) 100 tablet2018-10-010000-00-00NoNoCurrent
53002-2920-35300229200330 TABLET in 1 BOTTLE (53002-2920-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-2920-65300229200660 TABLET in 1 BOTTLE (53002-2920-6) 60 tablet2018-10-010000-00-00NoNoCurrent