Home NDC 61748-301-01 Myorisan
Product NDC 61748-301
Requested package NDC 61748-301-01
11-digit product format 617480301
Labeler code 61748
Product ID 61748-301_3e34f054-8b03-4d79-821c-593120c49ea2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isotretinoin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Akorn Operating Company LLC
Application ANDA076485
Marketing category ANDA
Marketing start 2012-05-01
Marketing end 0000-00-00
Substance ISOTRETINOIN
Active strength 10 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A076485-001 MYORISAN ISOTRETINOIN 10MG CAPSULE / ORAL AB1 2012-01-19 A076485-002 MYORISAN ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2012-01-19 A076485-003 MYORISAN ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2012-01-19 A076485-004 MYORISAN ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2015-08-25
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 5 · 164 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 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 61748-301-01 2024-01-30 C162847 48780-1 1030e364-fd70-111a-e063-dadaa90a10e2 Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg 61748-301-11 2024-01-30 C162847 48780-1 1030e364-fd70-111a-e063-dadaa90a10e2 Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg 61748-301-13 2024-01-30 C162847 48780-1 1030e364-fd70-111a-e063-dadaa90a10e2 Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61748-301-01 Myorisan 5000 in 1 BAG CAPSULE, LIQUID FILLED 5000 14 61748-301-11 Myorisan 10 in 1 CARTON CAPSULE, LIQUID FILLED 10 14 61748-301-11 Myorisan 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 14 61748-301-13 Myorisan 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 14 61748-301-13 Myorisan 3 in 1 CARTON CAPSULE, LIQUID FILLED 3 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISOTRETINOIN ACTIVE INGREDIENT EH28UP18IF MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 ISOTRETINOIN ACTIVE MOIETY EH28UP18IF MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 .ALPHA.-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 AMMONIA INACTIVE INGREDIENT 5138Q19F1X MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 HYDROGENATED SOYBEAN OIL INACTIVE INGREDIENT A2M91M918C MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 SHELLAC INACTIVE INGREDIENT 46N107B71O MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 SORBITOL INACTIVE INGREDIENT 506T60A25R MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61748-301 MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [AKORN OPERATING COMPANY LLC] 14 Legacy NDC, 5 package rows 20221220_51ff6346-9256-4c01-9f52-417d13f2df05.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 Marketing start Marketing end Sample Exclude flag Status 61748-301-01 61748030101 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-301-01) 2012-05-01 0000-00-00 No No Current