Isoniazid

Product NDC
62135-709
11-digit product format
621350709
Labeler code
62135
Product ID
62135-709_2df7a936-6840-66cc-e063-6294a90ae096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA089776
Marketing category
ANDA
Marketing start
1988-06-13
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isoniazid
Listing expiration
2026-12-31

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
62135-709-90Isoniazid90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-709-90EA - Each62135-7097e01a7ee-1e62-41a4-9c13-5757fc3b7a3012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-709ISONIAZID TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20250215_2e09b1a5-9786-427f-bf00-be15b06eb7e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN2e09b1a5-9786-427f-bf00-be15b06eb7e72
197832isoniazid 300 MG Oral TabletSCD2e09b1a5-9786-427f-bf00-be15b06eb7e72
197832INH 300 MG Oral TabletSY2e09b1a5-9786-427f-bf00-be15b06eb7e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-709-906213507099090 TABLET in 1 BOTTLE (62135-709-90) 90 tablet2023-10-20NoNoHistorical