Home NDC 70710-1243 tofacitinib
Product NDC 70710-1243
11-digit product format 707101243
Labeler code 70710
Product ID 70710-1243_ac4bee46-e55b-46c7-a365-0cc6147f0b79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tofacitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA209829
Marketing category ANDA
Marketing start 2026-05-11
Substance TOFACITINIB CITRATE
Active strength 5 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209829-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 A209829-002 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A209829-001 TOFACITINIB CITRATE EQ 5MG BASE TABLET / ORAL AB 2023-03-13 a50c72e98297…2026-08-01 22:54:32 2026-06 A209829-002 TOFACITINIB CITRATE EQ 10MG BASE TABLET / ORAL AB 2026-06-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A209829-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209829-002 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base tofacitinib
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOFACITINIB CITRATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O1FF4DIV0D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1357541 Internal RxNorm lookup 2048566 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1243-6 tofacitinib 60 in 1 BOTTLE TABLET, FILM COATED 60 6 70710-1243-8 tofacitinib 180 in 1 BOTTLE TABLET, FILM COATED 180 6
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70710-1243-6 70710124306 60 TABLET, FILM COATED in 1 BOTTLE (70710-1243-6) 2026-05-11 No No Current 70710-1243-8 70710124308 180 TABLET, FILM COATED in 1 BOTTLE (70710-1243-8) 2026-05-11 No No Current