FDA.reportPublic FDA data

Isoniazid

Product NDC
0440-1655
11-digit product format
004401655
Labeler code
0440
Product ID
0440-1655_fd12cd86-bbb2-4a3d-81e3-6b46e5f11e37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA080937
Marketing category
ANDA
Marketing start
1972-09-01
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0440-1655-302020-01-31C16284748780-19d75b9d0-a834-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP 100 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1655-30Isoniazid30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-1655-30EA - Each0440-16559dd2e623-a75d-48ec-bfe7-14f134197e3112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1655ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]4Legacy NDC, 1 package rows20140403_0013c0c8-513a-48f3-a918-5bc1750c96a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN0013c0c8-513a-48f3-a918-5bc1750c96a74
197832isoniazid 300 MG Oral TabletSCD0013c0c8-513a-48f3-a918-5bc1750c96a74
197832INH 300 MG Oral TabletSY0013c0c8-513a-48f3-a918-5bc1750c96a74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-1655-300044016553030 in 1 BOTTLE, PLASTICHistorical