FDA.reportPublic FDA data

Isoniazid

Product NDC
21695-627
11-digit product format
216950627
Labeler code
21695
Product ID
21695-627_31f5280d-bed3-4be9-9e03-6d51cf6d9582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA087425
Marketing category
ANDA
Marketing start
1981-07-14
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-627-002019-09-24C16284748780-1934fe258-4b06-48b1-e053-8cdaa90a720aISONIAZID TABLETS, USP
21695-627-302019-09-24C16284748780-1934fe258-4b06-48b1-e053-8cdaa90a720aISONIAZID TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-627-00Isoniazid100 in 1 BOTTLETABLET1002
21695-627-30Isoniazid30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-627-00EA - Each21695-627f4524669-5169-41b2-90fe-c035d273ec1512012-07-24
21695-627-30EA - Each21695-627faf9cbac-8479-4a9c-bc40-f1396e5bb68312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-627ISONIAZID TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111118_c42a2926-8542-49aa-b61b-19a19a31bcb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNc42a2926-8542-49aa-b61b-19a19a31bcb42
197832isoniazid 300 MG Oral TabletSCDc42a2926-8542-49aa-b61b-19a19a31bcb42
197832INH 300 MG Oral TabletSYc42a2926-8542-49aa-b61b-19a19a31bcb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-627-0021695062700100 in 1 BOTTLEHistorical
21695-627-302169506273030 in 1 BOTTLEHistorical