FDA.reportPublic FDA data

Isoniazid

Product NDC
51079-083
11-digit product format
510790083
Labeler code
51079
Product ID
51079-083_2c63f06e-644c-83aa-e063-6394a90a879a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA080937
Marketing category
ANDA
Marketing start
1994-06-09
Marketing end
2026-11-30
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080937-002ISONIAZIDISONIAZID300MGTABLET / ORALApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A080937-002ISONIAZID300MGTABLET / ORALApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsoniazidISONIAZIDREMEDYREPACK INC.6dab7b7b-a3a9-47ef-b423-134bc6970d8b2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDBryant Ranch Prepackb6d6dccc-2577-4bbb-896e-5f75b65ee6ca2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDBryant Ranch Prepack9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c2025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDCoupler LLC38f4c4af-81da-9b0c-e063-6294a90a8b9d2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDGenus Lifesciencesf0b46d1d-2300-457d-a7bd-a88a3f8d22352025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDA-S Medication Solutionsd5039796-6ba0-4fa8-84f7-e47c63d451632025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDMylan Institutional Inc.60a6b514-fa7f-4bc7-85b0-e5a14fa56b592025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
ndc (product): 51079-083
IsoniazidISONIAZIDTeva Pharmaceuticals USA, Inc.9499f1cf-2f46-4047-8b71-90aee7dee8542021-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDAphena Pharma Solutions - Tennessee, LLCcb6f5638-2d3a-4334-b272-6b4772d32d032020-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937
IsoniazidISONIAZIDProficient Rx LP65e50989-d24c-4bb3-a041-d6aea2635ef12019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080937
application number: ANDA080937

Additional Listing Data#

Finished product
Yes
Brand name base
Isoniazid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISONIAZID300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V83O1VOZ8LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197832Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60a6b514-fa7f-4bc7-85b0-e5a14fa56b59Available on FDA.report

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
51079-083-01Isoniazid1 in 1 BLISTER PACKTABLET111
51079-083-20Isoniazid100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-083-01EA - Each51079-08340b5d3c1-c3a1-4d07-95b2-8d7163f97cc312012-07-24
51079-083-20EA - Each51079-08375a5777b-396b-45f1-9e8b-02b973f2079512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-083ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20250125_60a6b514-fa7f-4bc7-85b0-e5a14fa56b59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN60a6b514-fa7f-4bc7-85b0-e5a14fa56b5911
197832isoniazid 300 MG Oral TabletSCD60a6b514-fa7f-4bc7-85b0-e5a14fa56b5911
197832INH 300 MG Oral TabletSY60a6b514-fa7f-4bc7-85b0-e5a14fa56b5911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-083-01510790083011 in 1 BLISTER PACKHistorical
51079-083-2051079008320100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01) 100 blister pack1994-06-092026-11-30NoNoCurrent