Home NDC 69238-1259 Isotretinoin
Product NDC 69238-1259
11-digit product format 692381259
Labeler code 69238
Product ID 69238-1259_831e90e7-4cd9-44e1-8f94-b136bcba2b5b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216097
Marketing category ANDA
Marketing start 2025-10-10
Substance ISOTRETINOIN
Active strength 40 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216097-001 ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE / ORAL 2025-10-07 A216097-002 ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE / ORAL 2025-10-07 A216097-003 ISOTRETINOIN ISOTRETINOIN 25MG CAPSULE / ORAL 2025-10-07 A216097-004 ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE / ORAL 2025-10-07 A216097-005 ISOTRETINOIN ISOTRETINOIN 35MG CAPSULE / ORAL 2025-10-07 A216097-006 ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE / ORAL 2025-10-07
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 2026-02-19 14:30 UTC 2026-02 A216097-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-001 ISOTRETINOIN 10MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-002 ISOTRETINOIN 20MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-003 ISOTRETINOIN 25MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-004 ISOTRETINOIN 30MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-005 ISOTRETINOIN 35MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-006 ISOTRETINOIN 40MG CAPSULE / ORAL 2025-10-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Isotretinoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH28UP18IF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197843 Internal RxNorm lookup 197844 Internal RxNorm lookup 197845 Internal RxNorm lookup 403930 Internal RxNorm lookup 1547561 Internal RxNorm lookup 1547565 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 69238-1259-3 Isotretinoin 3 in 1 BOX CAPSULE 3 9 69238-1259-4 Isotretinoin 10 in 1 BLISTER PACK CAPSULE 10 9
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69238-1259-3 69238125903 3 BLISTER PACK in 1 BOX (69238-1259-3) / 10 CAPSULE in 1 BLISTER PACK (69238-1259-4) 3 blister pack 2025-10-10 No No Current 69238-1259-4 69238125904 10 in 1 BLISTER PACK Historical