Home NDC 43975-310 MIGLUSTAT
Product NDC 43975-310
11-digit product format 439750310
Labeler code 43975
Product ID 43975-310_589c114d-45f1-423a-8064-846060d968ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIGLUSTAT
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA208342
Marketing category ANDA
Marketing start 2018-04-17
Substance MIGLUSTAT
Active strength 100 mg/1
Pharmacologic classes Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208342-001 MIGLUSTAT MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208342-001 AB
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 2 · 41 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 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208342-001 MIGLUSTAT 100MG CAPSULE / ORAL AB 2018-04-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MIGLUSTAT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIGLUSTAT 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ADN3S497AZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 401938 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 43975-310-08 MIGLUSTAT 15 in 1 BLISTER PACK CAPSULE 15 7 43975-310-83 MIGLUSTAT 6 in 1 CARTON CAPSULE 6 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43975-310 MIGLUSTAT CAPSULE [ANI PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241215_d746749d-de15-4225-b806-59b0765d25ae.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 43975-310-08 43975031008 15 in 1 BLISTER PACK Historical 43975-310-83 43975031083 6 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08) 6 blister pack 2018-04-17 0000-00-00 No No Current