Home NDC 71904-300 OPFOLDA
Product NDC 71904-300
11-digit product format 719040300
Labeler code 71904
Product ID 71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name miglustat
Dosage form CAPSULE
Route ORAL
Labeler AMICUS THERAPEUTICS US, LLC
Application NDA215211
Marketing category NDA
Marketing start 2023-10-11
Substance MIGLUSTAT
Active strength 65 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 42 .
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 N215211-001 OPFOLDA MIGLUSTAT 65MG CAPSULE / ORAL RLD, RS 2023-09-28
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215211-001 10512677 2033-03-07 U-3726 2023-10-26 N215211-001 11278599 2033-03-07 U-3726 2023-10-26 N215211-001 12419937 2033-03-07 U-3726 2025-10-21 N215211-001 10208299 2035-09-30 U-3726 Drug substance, Drug product 2023-10-26 N215211-001 10961522 2035-09-30 U-3726 2023-10-26 N215211-001 11753632 2035-09-30 U-3726 2023-10-26 N215211-001 11278601 2036-12-29 U-3726 Drug product 2023-10-26 N215211-001 12414985 2036-12-29 U-3726 2025-10-21 N215211-001 10857212 2037-08-12 U-3726 2023-10-26 N215211-001 12246062 2038-09-16 U-3726 2025-03-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215211-001 NP 2026-09-28
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.
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 2026-08-18 06:07:40 2026-07 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215211-001 OPFOLDA 65MG CAPSULE / ORAL RLD, RS 2023-09-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 153 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215211-001 10512677 2033-03-07 U-3726 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 11278599 2033-03-07 U-3726 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 12419937 2033-03-07 U-3726 2025-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 10208299 2035-09-30 U-3726 Drug substance, Drug product 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 10961522 2035-09-30 U-3726 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 11753632 2035-09-30 U-3726 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 11278601 2036-12-29 U-3726 Drug product 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 12414985 2036-12-29 U-3726 2025-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 10857212 2037-08-12 U-3726 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215211-001 12246062 2038-09-16 U-3726 2025-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215211-001 10512677 2033-03-07 U-3726 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 11278599 2033-03-07 U-3726 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 12419937 2033-03-07 U-3726 2025-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 10208299 2035-09-30 U-3726 Drug substance, Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 10961522 2035-09-30 U-3726 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 11753632 2035-09-30 U-3726 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 11278601 2036-12-29 U-3726 Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 12414985 2036-12-29 U-3726 2025-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 10857212 2037-08-12 U-3726 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215211-001 12246062 2038-09-16 U-3726 2025-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 10512677 2033-03-07 U-3726 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 11278599 2033-03-07 U-3726 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 12419937 2033-03-07 U-3726 2025-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 10208299 2035-09-30 U-3726 Drug substance, Drug product 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 10961522 2035-09-30 U-3726 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 11753632 2035-09-30 U-3726 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 11278601 2036-12-29 U-3726 Drug product 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 12414985 2036-12-29 U-3726 2025-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 10857212 2037-08-12 U-3726 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215211-001 12246062 2038-09-16 U-3726 2025-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215211-001 10512677 2033-03-07 U-3726 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 11278599 2033-03-07 U-3726 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 10208299 2035-09-30 U-3726 Drug substance, Drug product 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 10961522 2035-09-30 U-3726 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 11753632 2035-09-30 U-3726 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 11278601 2036-12-29 U-3726 Drug product 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 10857212 2037-08-12 U-3726 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215211-001 12246062 2038-09-16 U-3726 2025-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215211-001 10512677 2033-03-07 U-3726 2023-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215211-001 11278599 2033-03-07 U-3726 2023-10-26 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base OPFOLDA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIGLUSTAT 65 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2667426 Internal RxNorm lookup 2667432 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 71904-300-01 OPFOLDA 1 in 1 BOTTLE, PLASTIC CAPSULE 1 5 71904-300-01 OPFOLDA 4 in 1 BOTTLE, PLASTIC CAPSULE 4 5 71904-300-02 OPFOLDA 1 in 1 BOTTLE, PLASTIC CAPSULE 1 5 71904-300-02 OPFOLDA 24 in 1 BOTTLE, PLASTIC CAPSULE 24 5 71904-300-03 OPFOLDA 100 in 1 BOTTLE, PLASTIC CAPSULE 100 5 71904-300-03 OPFOLDA 1 in 1 BOTTLE, PLASTIC CAPSULE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71904-300 OPFOLDA (MIGLUSTAT) CAPSULE [AMICUS THERAPEUTICS US, LLC] 5 Current NDC, 6 package rows 20241207_d7c38298-37db-5a80-e053-2995a90aee40.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 Marketing start Sample Exclude flag Status 71904-300-01 71904030001 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC 2023-10-11 No No Current 71904-300-02 71904030002 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC 2023-10-11 No No Current 71904-300-03 71904030003 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC 2023-10-11 No No Current