Prescription drug · NDA
Galafold (Migalastat hydrochloride) NDC 71904-100
Migalastat hydrochloride 123 mg/1 · Capsule · Oral · Amicus Therapeutics US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71904-100-01 | 71904010001 | 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACKMarketed from Aug 10, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Galafold
- Generic name (nonproprietary)
- migalastat hydrochloride
- Active ingredients
- Migalastat hydrochloride — 123 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amicus Therapeutics US, LLCNDC labeler code 71904
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208623
- Marketing start
- Listing expires
- Identifiers
- Product ID 71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139SPL ID 2da6bbb5-63ae-4405-a1ad-25429b9f7139SPL set ID 66dbd928-0f1c-48b1-a832-54e4abd9f1dbRxCUI 2054257, 2054263, 2054266, 2054275UNII CLY7M0XD20UPC 0371904100012
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471904010001followed by a unit qualifier and the quantityPackage 71904-0100-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
GALAFOLD is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene ( GLA ) variant based on in vitro assay data [see Dosage and Administration (2.1) and Clinical Pharmacology (12.1) ] . This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. GALAFOLD is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a con…
Excerpt only. Read the full label for complete information.
About NDC 71904-100
- What is NDC 71904-100?
- 71904-100 is the product NDC for Galafold (migalastat hydrochloride), Migalastat hydrochloride 123 mg/1 capsule, listed with the FDA by Amicus Therapeutics US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Galafold (Migalastat hydrochloride).
- What is the active ingredient?
- Migalastat hydrochloride.
- Who is the labeler?
- Amicus Therapeutics US, LLC, NDC labeler code 71904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Galafold?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.