Isoniazid

Product NDC
71335-2760
11-digit product format
713352760
Labeler code
71335
Product ID
71335-2760_657e6a8b-60c8-45bc-a044-6af78841400e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA080937
Marketing category
ANDA
Marketing start
2024-11-01
Marketing end
2028-02-28
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
71335-2760-1Isoniazid30 in 1 BOTTLETABLET30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2760-1EA - Each71335-2760a98a881e-0873-41c9-b9c5-622f36e2b50c12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c101
197832isoniazid 300 MG Oral TabletSCD9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c101
197832INH 300 MG Oral TabletSY9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2760-17133527600130 TABLET in 1 BOTTLE (71335-2760-1) 30 tablet2024-11-012028-02-28NoNoHistorical