FDA.reportPublic FDA data

isoniazid

Product NDC
81665-108
11-digit product format
816650108
Labeler code
81665
Product ID
81665-108_3966e8ed-31f4-6d0a-e063-6294a90a3233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
OMNIVIUM PHARMACEUTICALS LLC.
Application
ANDA040090
Marketing category
ANDA
Marketing start
2024-10-15
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, 311166

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
81665-108-10isoniazid100 in 1 BOTTLE, PLASTICTABLET1002
81665-108-30isoniazid30 in 1 BOTTLE, PLASTICTABLET302
81665-108-51isoniazid1000 in 1 BOTTLE, PLASTICTABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81665-108-10EA - Each81665-1089fcc480a-1ca6-40b1-b31b-d10c31010de812024-12-10
81665-108-30EA - Each81665-108be58eb53-31be-46c6-a51e-31b8ecb5845912025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81665-108ISONIAZID TABLET [OMNIVIUM PHARMACEUTICALS LLC.]1Current NDC, 3 package rows20241022_35400f1d-fd25-4bfa-a382-ac390e21bf2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNeeaf09a3-5631-4089-9f17-15750c002e32100
197832isoniazid 300 MG Oral TabletSCDeeaf09a3-5631-4089-9f17-15750c002e32100
197832INH 300 MG Oral TabletSYeeaf09a3-5631-4089-9f17-15750c002e32100
197832isoniazid 300 MG Oral TabletPSN93252cc8-c8d4-401b-bde5-ca8a3b57651e4
197832isoniazid 300 MG Oral TabletSCD93252cc8-c8d4-401b-bde5-ca8a3b57651e4
197832INH 300 MG Oral TabletSY93252cc8-c8d4-401b-bde5-ca8a3b57651e4
311166isoniazid 100 MG Oral TabletPSN35400f1d-fd25-4bfa-a382-ac390e21bf2e2
197832isoniazid 300 MG Oral TabletPSN35400f1d-fd25-4bfa-a382-ac390e21bf2e2
311166isoniazid 100 MG Oral TabletSCD35400f1d-fd25-4bfa-a382-ac390e21bf2e2
197832isoniazid 300 MG Oral TabletSCD35400f1d-fd25-4bfa-a382-ac390e21bf2e2
311166INH 100 MG Oral TabletSY35400f1d-fd25-4bfa-a382-ac390e21bf2e2
197832INH 300 MG Oral TabletSY35400f1d-fd25-4bfa-a382-ac390e21bf2e2
197832isoniazid 300 MG Oral TabletPSN44592c5c-d11c-148d-e063-6294a90ab35c1
197832isoniazid 300 MG Oral TabletPSNed780e28-a2c3-44dc-898a-d2cbe05eeedf1
197832isoniazid 300 MG Oral TabletSCD44592c5c-d11c-148d-e063-6294a90ab35c1
197832isoniazid 300 MG Oral TabletSCDed780e28-a2c3-44dc-898a-d2cbe05eeedf1
197832INH 300 MG Oral TabletSY44592c5c-d11c-148d-e063-6294a90ab35c1
197832INH 300 MG Oral TabletSYed780e28-a2c3-44dc-898a-d2cbe05eeedf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81665-108-1081665010810100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10) 100 tablet2024-10-15NoNoHistorical
81665-108-308166501083030 TABLET in 1 BOTTLE, PLASTIC (81665-108-30) 30 tablet2024-10-15NoNoHistorical
81665-108-51816650108511000 TABLET in 1 BOTTLE, PLASTIC (81665-108-51) 1000 tablet2024-10-15NoNoHistorical