FDA.reportPublic FDA data

Galafold

Product NDC
71904-100
11-digit product format
719040100
Labeler code
71904
Product ID
71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
migalastat hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amicus Therapeutics US, LLC
Application
NDA208623
Marketing category
NDA
Marketing start
2018-08-10
Substance
MIGALASTAT HYDROCHLORIDE
Active strength
123 mg/1
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208623-001GALAFOLDMIGALASTAT HYDROCHLORIDEEQ 123MG BASECAPSULE / ORALRLD, RS2018-08-10

Orange Book patents#

Current patent rows page 1 of 1 · 67 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208623-001103838642027-05-16U-23712019-09-04
N208623-001104061432027-05-16U-23712019-09-26
N208623-001112414222027-05-16U-23712022-02-25
N208623-00190000112027-05-16U-23712018-09-05
N208623-00194806822027-05-16U-23712018-09-05
N208623-00199872632027-05-16U-23712018-09-05
N208623-001105250452028-04-28U-23712020-01-17
N208623-001109258662028-04-28U-23712021-03-18
N208623-001110335382028-04-28U-23712021-07-12
N208623-001125995952028-04-28U-23712026-04-24
N208623-00199996182028-04-28U-23722018-09-05
N208623-00199996182028-04-28U-23732018-09-05
N208623-001108139212029-02-12U-23712020-11-18
N208623-00185923622029-02-12U-2371Delist requested2018-09-05
N208623-00190955842029-02-12U-23712018-09-05
N208623-001RE486082031-10-20U-23712021-07-22
N208623-001125995942036-07-19U-23712026-04-24
N208623-001100765142037-03-15U-23712018-10-18
N208623-001112349722037-03-15U-23712022-02-25
N208623-001102518732038-05-30U-23712019-05-07
N208623-001104710532038-05-30U-23712019-12-06
N208623-001107922782038-05-30U-23712020-10-15
N208623-001107922792038-05-30U-23712020-10-15
N208623-001107994912038-05-30U-23712020-11-05
N208623-001108067272038-05-30U-23712020-11-05
N208623-001108498892038-05-30U-23712020-12-17
N208623-001108498902038-05-30U-23712020-12-17
N208623-001108571412038-05-30U-23712020-12-17
N208623-001108571422038-05-30U-23712020-12-17
N208623-001108746552038-05-30U-23712021-01-07
N208623-001108746562038-05-30U-23712021-01-07
N208623-001108746572038-05-30U-23712021-01-07
N208623-001112785362038-05-30U-23712022-04-07
N208623-001112785372038-05-30U-23712022-04-07
N208623-001112785382038-05-30U-23712022-04-07
N208623-001112785392038-05-30U-23712022-04-07
N208623-001112785402038-05-30U-23712022-04-07
N208623-001113049402038-05-30Drug substance2022-04-19
N208623-001113577612038-05-30U-23712022-06-28
N208623-001113577622038-05-30U-23712022-06-28
N208623-001113577632038-05-30U-23712022-06-28
N208623-001113577642038-05-30Drug substance2022-06-28
N208623-001113577652038-05-30Drug substance2022-06-28
N208623-001113762442038-05-30Drug substance2022-07-25
N208623-001113894362038-05-30U-23712022-07-25
N208623-001113894372038-05-30U-23712022-07-25
N208623-001114263962038-05-30Drug substance2022-09-02
N208623-001114581282038-05-30U-23712022-10-13
N208623-001116125932038-05-30Drug substance2023-04-17
N208623-001116125942038-05-30Drug substance2023-04-17
N208623-001116333872038-05-30Drug substance2023-05-12
N208623-001116665642038-05-30U-23712023-06-09
N208623-001117865162038-05-30Drug substance2023-10-25
N208623-001118132552038-05-30U-23712023-12-08
N208623-001120424882038-05-30Drug substance2024-07-30
N208623-001120424892038-05-30U-2371Drug substance2024-07-30
N208623-001120424902038-05-30U-23712024-07-30
N208623-001121092052038-05-30U-2371Drug substance2024-10-15
N208623-001122800422038-05-30U-2371Drug substance2025-05-07
N208623-001119039382038-08-17U-2371Drug substance2024-03-04
N208623-001113577842039-02-06U-23712022-06-28
N208623-001118263602039-02-16Drug substance2023-12-08
N208623-001116423342039-02-20U-23712023-05-12
N208623-001116229622039-03-17Drug substance2023-04-17
N208623-001116333882039-03-25U-23712023-05-12
N208623-001125942682041-05-23U-23712026-04-24
N208623-001118331642042-01-11U-23712023-12-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208623-001GALAFOLDEQ 123MG BASECAPSULE / ORALRLD, RS2018-08-10a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208623-001103838642027-05-16U-23712019-09-04a50c72e98297…
2026-08-01 22:54:322026-06N208623-001104061432027-05-16U-23712019-09-26a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112414222027-05-16U-23712022-02-25a50c72e98297…
2026-08-01 22:54:322026-06N208623-00190000112027-05-16U-23712018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-00194806822027-05-16U-23712018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-00199872632027-05-16U-23712018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-001105250452028-04-28U-23712020-01-17a50c72e98297…
2026-08-01 22:54:322026-06N208623-001109258662028-04-28U-23712021-03-18a50c72e98297…
2026-08-01 22:54:322026-06N208623-001110335382028-04-28U-23712021-07-12a50c72e98297…
2026-08-01 22:54:322026-06N208623-001125995952028-04-28U-23712026-04-24a50c72e98297…
2026-08-01 22:54:322026-06N208623-00199996182028-04-28U-23732018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-00199996182028-04-28U-23722018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108139212029-02-12U-23712020-11-18a50c72e98297…
2026-08-01 22:54:322026-06N208623-00185923622029-02-12U-2371Delist requested2018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-00190955842029-02-12U-23712018-09-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-001RE486082031-10-20U-23712021-07-22a50c72e98297…
2026-08-01 22:54:322026-06N208623-001125995942036-07-19U-23712026-04-24a50c72e98297…
2026-08-01 22:54:322026-06N208623-001100765142037-03-15U-23712018-10-18a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112349722037-03-15U-23712022-02-25a50c72e98297…
2026-08-01 22:54:322026-06N208623-001102518732038-05-30U-23712019-05-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001104710532038-05-30U-23712019-12-06a50c72e98297…
2026-08-01 22:54:322026-06N208623-001107922782038-05-30U-23712020-10-15a50c72e98297…
2026-08-01 22:54:322026-06N208623-001107922792038-05-30U-23712020-10-15a50c72e98297…
2026-08-01 22:54:322026-06N208623-001107994912038-05-30U-23712020-11-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108067272038-05-30U-23712020-11-05a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108498892038-05-30U-23712020-12-17a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108498902038-05-30U-23712020-12-17a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108571412038-05-30U-23712020-12-17a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108571422038-05-30U-23712020-12-17a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108746552038-05-30U-23712021-01-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108746562038-05-30U-23712021-01-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001108746572038-05-30U-23712021-01-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112785362038-05-30U-23712022-04-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112785372038-05-30U-23712022-04-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112785382038-05-30U-23712022-04-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112785392038-05-30U-23712022-04-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001112785402038-05-30U-23712022-04-07a50c72e98297…
2026-08-01 22:54:322026-06N208623-001113049402038-05-30Drug substance2022-04-19a50c72e98297…
2026-08-01 22:54:322026-06N208623-001113577612038-05-30U-23712022-06-28a50c72e98297…
2026-08-01 22:54:322026-06N208623-001113577622038-05-30U-23712022-06-28a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GalafoldMIGALASTAT HYDROCHLORIDEAmicus Therapeutics US, LLC66dbd928-0f1c-48b1-a832-54e4abd9f1db2025-08-28Adverse reactionsExact identifier
application applno (NDA): 208623
application number: NDA208623
ndc (product): 71904-100

Additional Listing Data#

Finished product
Yes
Brand name base
Galafold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIGALASTAT HYDROCHLORIDE123 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CLY7M0XD20Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2054257Internal RxNorm lookup
2054263Internal RxNorm lookup
2054266Internal RxNorm lookup
2054275Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66dbd928-0f1c-48b1-a832-54e4abd9f1dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bb8531f-3733-4c31-b584-fecd5cd5fb2fProduct name120181029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71904-100-01Galafold1 in 1 BLISTER PACKCAPSULE118
71904-100-01Galafold14 in 1 CARTONCAPSULE1418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71904-100-01EA - Each71904-100b268f47f-2a99-45c3-b440-afd6557b37cb12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71904-100GALAFOLD (MIGALASTAT HYDROCHLORIDE) CAPSULE [AMICUS THERAPEUTICS US, LLC]17Current NDC, Legacy NDC, 2 package rows20250406_66dbd928-0f1c-48b1-a832-54e4abd9f1db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054275{14 (migalastat 123 MG Oral Capsule [Galafold]) } Pack [Galafold 28 Day Wallet]BPCK66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054266{14 (migalastat 123 MG Oral Capsule) } PackGPCK66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054275Galafold 123 MG 28 Day (4 Week) Wallet PackPSN66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054263Galafold 123 MG Oral CapsulePSN66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054266migALAstat 123 MG 28 Day (4 Week) Wallet PackPSN66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054257migALAstat 123 MG Oral CapsulePSN66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054263migalastat 123 MG Oral Capsule [Galafold]SBD66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054257migalastat 123 MG Oral CapsuleSCD66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054266{14 (migalastat 123 MG (as migalastat HCl 150 MG) Oral Capsule)} PackSY66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054263Galafold 123 MG (as migalastat HCl 150 MG) Oral CapsuleSY66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054275Galafold 123 MG 28 Day (4 Week) Wallet PackSY66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054263Galafold 123 MG Oral CapsuleSY66dbd928-0f1c-48b1-a832-54e4abd9f1db18
2054257migalastat 123 MG (as migalastat HCl 150 MG) Oral CapsuleSY66dbd928-0f1c-48b1-a832-54e4abd9f1db18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71904-100-017190401000114 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK14 blister pack2018-08-100000-00-00NoNoCurrent