Isoniazid

Product NDC
55695-027
11-digit product format
556950027
Labeler code
55695
Product ID
55695-027_2dcb1a5f-a1db-3686-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
ANDA080936
Marketing category
ANDA
Marketing start
1972-09-01
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
100 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
55695-027-002020-01-31C16284748780-19d75b9d0-e2e4-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP 100 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-027-00Isoniazid100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-027ISONIAZID TABLET [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]2Legacy NDC, 1 package rows20160311_2b87aa05-8028-1b46-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311166isoniazid 100 MG Oral TabletPSN2b87aa05-8028-1b46-e054-00144ff8d46c2
197832isoniazid 300 MG Oral TabletPSN2b87aa05-8028-1b46-e054-00144ff8d46c2
311166isoniazid 100 MG Oral TabletSCD2b87aa05-8028-1b46-e054-00144ff8d46c2
197832isoniazid 300 MG Oral TabletSCD2b87aa05-8028-1b46-e054-00144ff8d46c2
311166INH 100 MG Oral TabletSY2b87aa05-8028-1b46-e054-00144ff8d46c2
197832INH 300 MG Oral TabletSY2b87aa05-8028-1b46-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-027-0055695002700100 in 1 BOTTLEHistorical