FDA.reportPublic FDA data

tofacitinib

Product NDC
70710-1353
11-digit product format
707101353
Labeler code
70710
Product ID
70710-1353_ad974169-bcc9-4043-9ed1-201f13d8fd22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tofacitinib
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA214264
Marketing category
ANDA
Marketing start
2026-05-20
Substance
TOFACITINIB CITRATE
Active strength
11 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A214264-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19
A214264-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214264-001AB
A214264-002AB

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 22:54:322026-06A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19a50c72e98297…
2026-08-01 22:54:322026-06A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214264-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214264-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tofacitinibTOFACITINIBZydus Lifesciences Limitedac0b26d5-1352-42ff-b5ea-3eb02d8508a42026-05-12Exact identifier
application applno (ANDA): 214264
application number: ANDA214264
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214264
application number: ANDA214264
ndc (product): 70710-1353

Additional Listing Data#

Finished product
Yes
Brand name base
tofacitinib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB CITRATE11 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O1FF4DIV0DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1741046Internal RxNorm lookup
2273113Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
179ffbb2-bedc-40e6-b77b-33d4f7832172Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6Product name420250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1353-3tofacitinib30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
70710-1353-9tofacitinib90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741046tofacitinib 11 MG 24HR Extended Release Oral TabletPSN179ffbb2-bedc-40e6-b77b-33d4f78321726
2273113tofacitinib 22 MG 24HR Extended Release Oral TabletPSN179ffbb2-bedc-40e6-b77b-33d4f78321726
174104624 HR tofacitinib 11 MG Extended Release Oral TabletSCD179ffbb2-bedc-40e6-b77b-33d4f78321726
227311324 HR tofacitinib 22 MG Extended Release Oral TabletSCD179ffbb2-bedc-40e6-b77b-33d4f78321726
1741046tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY179ffbb2-bedc-40e6-b77b-33d4f78321726
1741046tofacitinib 11 MG 24 HR Extended Release Oral TabletSY179ffbb2-bedc-40e6-b77b-33d4f78321726

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741046tofacitinib 11 MG 24HR Extended Release Oral TabletPSN179ffbb2-bedc-40e6-b77b-33d4f78321726
2273113tofacitinib 22 MG 24HR Extended Release Oral TabletPSN179ffbb2-bedc-40e6-b77b-33d4f78321726
174104624 HR tofacitinib 11 MG Extended Release Oral TabletSCD179ffbb2-bedc-40e6-b77b-33d4f78321726
227311324 HR tofacitinib 22 MG Extended Release Oral TabletSCD179ffbb2-bedc-40e6-b77b-33d4f78321726
1741046tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY179ffbb2-bedc-40e6-b77b-33d4f78321726
1741046tofacitinib 11 MG 24 HR Extended Release Oral TabletSY179ffbb2-bedc-40e6-b77b-33d4f78321726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1353-37071013530330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-3) 2026-05-20NoNoCurrent
70710-1353-97071013530990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-9) 2026-05-20NoNoCurrent