Home NDC 70771-1933-2 Tretinoin
Product NDC 70771-1933
Requested package NDC 70771-1933-2
11-digit product format 707711933
Labeler code 70771
Product ID 70771-1933_1df91300-7a8d-4354-8451-512247804a71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Zydus Lifesciences Limited
Application ANDA218560
Marketing category ANDA
Marketing start 2026-10-01
Substance TRETINOIN
Active strength .25 mg/g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
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 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218560-001 TRETINOIN TRETINOIN 0.025% CREAM / TOPICAL AB 2026-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218560-001 AB
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 2026-10-15 13:18:30 2026-09 A218560-001 TRETINOIN 0.025% CREAM / TOPICAL AB 2026-09-15 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A218560-001 AB 1 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tretinoin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRETINOIN .25 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70771-1933-2 70771193302 1 TUBE in 1 CARTON (70771-1933-2) / 20 g in 1 TUBE 1 tube 2026-10-01 No No Current