Home NDC 0378-6612 Amnesteem
Product NDC 0378-6612
11-digit product format 003786612
Labeler code 0378
Product ID 0378-6612_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 2002-11-11
Substance ISOTRETINOIN
Active strength 20 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 20 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 0378-6612-85 Amnesteem 10 in 1 BLISTER PACK CAPSULE 10 23 0378-6612-93 Amnesteem 3 in 1 CARTON CAPSULE 3 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISOTRETINOIN ACTIVE INGREDIENT EH28UP18IF AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 ISOTRETINOIN ACTIVE MOIETY EH28UP18IF AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 ISOTRETINOIN ACTIVE INGREDIENT EH28UP18IF AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 ISOTRETINOIN ACTIVE MOIETY EH28UP18IF AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V AMNESTEEM (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-6612 AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 22 Current NDC, Legacy 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 Marketing end Sample Exclude flag Status 0378-6612-85 00378661285 10 in 1 BLISTER PACK Historical 0378-6612-93 00378661293 3 BLISTER PACK in 1 CARTON (0378-6612-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6612-85) 3 blister pack 2002-11-11 0000-00-00 No No Current