FDA.reportPublic FDA data

isoniazid

Product NDC
10135-804
Requested package NDC
10135-804-01
11-digit product format
101350804
Labeler code
10135
Product ID
10135-804_3e871908-abb7-9d35-e063-6394a90ac63d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA040090
Marketing category
ANDA
Marketing start
2025-03-01
Substance
ISONIAZID
Active strength
100 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040090-001ISONIAZIDISONIAZID100MGTABLET / ORALAARS1997-06-26
A040090-002ISONIAZIDISONIAZID300MGTABLET / ORALAARS1997-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040090-001AA
A040090-002AA

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 22:54:322026-06A040090-001ISONIAZID100MGTABLET / ORALAARS1997-06-26a50c72e98297…
2026-08-01 22:54:322026-06A040090-002ISONIAZID300MGTABLET / ORALAARS1997-06-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040090-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040090-002AA1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
isoniazidISONIAZIDREMEDYREPACK INC.93252cc8-c8d4-401b-bde5-ca8a3b57651e2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090
isoniazidISONIAZIDCoupler LLC44592c5c-d11c-148d-e063-6294a90ab35c2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090
isoniazidISONIAZIDA-S Medication Solutionsed780e28-a2c3-44dc-898a-d2cbe05eeedf2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090
isoniazidISONIAZIDMarlex Pharmaceuticals, Inc.312cd403-b211-64ef-e063-6394a90aab882025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090
ndc (package): 10135-804-01
ndc (product): 10135-804
ndc11 (package): 10135080401
isoniazidISONIAZIDOMNIVIUM PHARMACEUTICALS LLC.35400f1d-fd25-4bfa-a382-ac390e21bf2e2025-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090
isoniazidISONIAZIDBryant Ranch Prepackeeaf09a3-5631-4089-9f17-15750c002e322025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090
isoniazidISONIAZIDBryant Ranch Prepack63bf1fe0-5d74-4123-88b7-a95d521befca2025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040090
application number: ANDA040090

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISONIAZID100 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197832Internal RxNorm lookup
311166Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
312cd403-b211-64ef-e063-6394a90aab88Available 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
10135-804-01isoniazid100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-804-01EA - Each10135-804b2299530-3943-4159-928d-6df936b4a06d12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-804ISONIAZID TABLET [MARLEX PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20250406_312cd403-b211-64ef-e063-6394a90aab88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311166isoniazid 100 MG Oral TabletPSN312cd403-b211-64ef-e063-6394a90aab883
197832isoniazid 300 MG Oral TabletPSN312cd403-b211-64ef-e063-6394a90aab883
311166isoniazid 100 MG Oral TabletSCD312cd403-b211-64ef-e063-6394a90aab883
197832isoniazid 300 MG Oral TabletSCD312cd403-b211-64ef-e063-6394a90aab883
311166INH 100 MG Oral TabletSY312cd403-b211-64ef-e063-6394a90aab883
197832INH 300 MG Oral TabletSY312cd403-b211-64ef-e063-6394a90aab883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-804-0110135080401100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01) 100 tablet2025-03-01NoNoCurrent