Home NDC 0378-6613 Amnesteem
Product NDC 0378-6613
11-digit product format 003786613
Labeler code 0378
Product ID 0378-6613_8105505f-9df6-4bc4-b201-7281a2d3af00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isotretinoin
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA075945
Marketing category ANDA
Marketing start 2025-04-10
Substance ISOTRETINOIN
Active strength 30 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075945-001 AMNESTEEM ISOTRETINOIN 10MG CAPSULE / ORAL AB1 2002-11-08 A075945-002 AMNESTEEM ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2002-11-08 A075945-003 AMNESTEEM ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2002-11-08 A075945-004 AMNESTEEM ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2025-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 · 127 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 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075945-004 AMNESTEEM 30MG CAPSULE / ORAL AB1 2025-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075945-004 AMNESTEEM 30MG CAPSULE / ORAL AB1 2025-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075945-004 AMNESTEEM 30MG CAPSULE / ORAL AB1 2025-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075945-002 AMNESTEEM 20MG CAPSULE / ORAL AB1 2002-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075945-003 AMNESTEEM 40MG CAPSULE / ORAL AB1 2002-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075945-001 AMNESTEEM 10MG CAPSULE / ORAL AB1 2002-11-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 127 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amnesteem
Listing expiration 2026-12-31 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 · 8 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 404058 Internal RxNorm lookup 404061 Internal RxNorm lookup 404064 Internal RxNorm lookup 2711694 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 0378-6613-85 Amnesteem 10 in 1 BLISTER PACK CAPSULE 10 23 0378-6613-93 Amnesteem 3 in 1 CARTON CAPSULE 3 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-6613 AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 22 Current NDC, 2 package rows 20250412_b2cb63c9-f825-4991-9a2c-6260f1bbcc2c.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 · 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 0378-6613-85 00378661385 10 in 1 BLISTER PACK Historical 0378-6613-93 00378661393 3 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6613-85) 3 blister pack 2025-04-10 No No Current