Home NDC 0245-0573 Isotretinoin
Product NDC 0245-0573
11-digit product format 002450573
Labeler code 0245
Product ID 0245-0573_4ab8d5b7-3bd6-255a-e063-6294a90ae2cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA212333
Marketing category ANDA
Marketing start 2021-09-21
Substance ISOTRETINOIN
Active strength 30 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 1 .
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 A212333-001 ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 A212333-002 ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 A212333-003 ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21
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.
Product history page 1 of 3 · 99 observed 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 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212333-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212333-003 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212333-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-09-21 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isotretinoin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 30 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197843 Internal RxNorm lookup 197844 Internal RxNorm lookup 403930 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 0245-0573-01 Isotretinoin 3 in 1 BOX CAPSULE, LIQUID FILLED 3 4 0245-0573-89 Isotretinoin 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0573 ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20221029_08529687-26b2-41e5-b6fb-35b4c0d891fe.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0245-0573-01 00245057301 3 BLISTER PACK in 1 BOX (0245-0573-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0573-89) 3 blister pack 2021-09-21 0000-00-00 No No Current 0245-0573-89 00245057389 10 in 1 BLISTER PACK Historical