Isoniazid

Product NDC
10135-584
11-digit product format
101350584
Labeler code
10135
Product ID
10135-584_f8a56779-f03a-45a6-a237-7a55a7c149a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA089776
Marketing category
ANDA
Marketing start
2014-10-01
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
10135-584-012020-01-31C16284748780-19d75b9cf-dae7-f424-e053-dadaa90a57ceIsoniazid Tablet
10135-584-102020-01-31C16284748780-19d75b9cf-dae7-f424-e053-dadaa90a57ceIsoniazid Tablet
10135-584-302020-01-31C16284748780-19d75b9cf-dae7-f424-e053-dadaa90a57ceIsoniazid Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-584-01Isoniazid100 in 1 BOTTLE, PLASTICTABLET1001
10135-584-10Isoniazid1000 in 1 BOTTLETABLET10001
10135-584-30Isoniazid30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-584-01EA - Each10135-584e0e8b957-1011-4638-a96c-6ca20253847212016-03-04
10135-584-30EA - Each10135-58415e4bbe7-45ba-4569-b6f7-9636e64a14c312016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-584ISONIAZID TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 3 package rows20160210_b9e6aa9e-c905-4774-b4d4-ae6acc2f64a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNb9e6aa9e-c905-4774-b4d4-ae6acc2f64a11
197832isoniazid 300 MG Oral TabletSCDb9e6aa9e-c905-4774-b4d4-ae6acc2f64a11
197832INH 300 MG Oral TabletSYb9e6aa9e-c905-4774-b4d4-ae6acc2f64a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-584-0110135058401100 in 1 BOTTLE, PLASTICHistorical
10135-584-10101350584101000 in 1 BOTTLEHistorical
10135-584-301013505843030 in 1 BOTTLEHistorical