Home NDC 84386-011-03 Isotretinoin
Product NDC 84386-011
Requested package NDC 84386-011-03
11-digit product format 843860011
Labeler code 84386
Product ID 84386-011_9f75ad9f-40e7-4e6a-b722-f4c3e0be3432
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA220336
Marketing category ANDA
Marketing start 2026-09-10
Substance ISOTRETINOIN
Active strength 40 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220336-001 ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2026-09-10 A220336-002 ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2026-09-10 A220336-003 ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2026-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-10-15 13:18:30 2026-09 A220336-001 ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220336-002 ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220336-003 ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2026-09-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220336-001 ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2026-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220336-002 ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2026-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220336-003 ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2026-09-10 84e616aacf4f…
Observed Orange Book normalized TE history# 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 Isotretinoin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 40 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84386-011-03 84386001103 3 BLISTER PACK in 1 CARTON (84386-011-03) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2026-09-10 No No Current