Isoniazid

Product NDC
60687-553
11-digit product format
606870553
Labeler code
60687
Product ID
60687-553_2d6aaea5-0c84-d50d-e063-6394a90ac97c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA080937
Marketing category
ANDA
Marketing start
2020-10-28
Marketing end
2026-07-31
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isoniazid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISONIAZID300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV83O1VOZ8L
Rxcui197832

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-553-01Isoniazid100 in 1 BOX, UNIT-DOSETABLET1007
60687-553-11Isoniazid1 in 1 BLISTER PACKTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-553ISONIAZID TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20250207_df71204a-9962-4a61-bf72-cd8cfd930fc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNdf71204a-9962-4a61-bf72-cd8cfd930fc57
197832isoniazid 300 MG Oral TabletSCDdf71204a-9962-4a61-bf72-cd8cfd930fc57
197832INH 300 MG Oral TabletSYdf71204a-9962-4a61-bf72-cd8cfd930fc57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-553-0160687055301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-553-01) / 1 TABLET in 1 BLISTER PACK (60687-553-11) 100 blister pack2020-10-282026-07-31NoNoCurrent
60687-553-11606870553111 in 1 BLISTER PACKHistorical