FDA.reportPublic FDA data

MIMRYLO

Product NDC
63020-725
Requested package NDC
63020-725-20
11-digit product format
630200725
Labeler code
63020
Product ID
63020-725_2fc41c37-8a81-4171-a52c-e9317c0c34cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rusfertide
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA220605
Marketing category
NDA
Marketing start
2026-08-28
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220605-001MIMRYLORUSFERTIDE ACETATEEQ 9.5MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-28
N220605-002MIMRYLORUSFERTIDE ACETATEEQ 19MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-28
N220605-003MIMRYLORUSFERTIDE ACETATEEQ 28MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-28
N220605-004MIMRYLORUSFERTIDE ACETATEEQ 41MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-28
N220605-005MIMRYLORUSFERTIDE ACETATEEQ 54MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220605-001MIMRYLOEQ 9.5MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N220605-002MIMRYLOEQ 19MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N220605-003MIMRYLOEQ 28MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N220605-004MIMRYLOEQ 41MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N220605-005MIMRYLOEQ 54MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-08-2884e616aacf4f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MIMRYLO
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2751601Internal RxNorm lookup
2751606Internal RxNorm lookup
2751608Internal RxNorm lookup
2751610Internal RxNorm lookup
2751612Internal RxNorm lookup
2751614Internal RxNorm lookup
2751616Internal RxNorm lookup
2751618Internal RxNorm lookup
2751620Internal RxNorm lookup
2751622Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
101aff01-31ed-4841-a8b6-0a5a8503189bAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIMRYLORUSFERTIDETakeda Pharmaceuticals America, Inc.101aff01-31ed-4841-a8b6-0a5a8503189b2026-08-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 220605
application number: NDA220605
ndc (package): 63020-725-20
ndc (product): 63020-725
ndc11 (package): 63020072520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63020-725-20630200725201 KIT in 1 CARTON (63020-725-20) * 19 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63020-720-20) * .6 mL in 1 SYRINGE (63020-600-05) 1 kit2026-08-28NoNoCurrent