FDA.reportPublic FDA data

Increlex

Product NDC
15054-1040
11-digit product format
150541040
Labeler code
15054
Product ID
15054-1040_21eb91ba-3cd8-47f0-a27b-35e3e5fd2e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mecasermin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Ipsen Biopharmaceuticals, Inc.
Application
BLA021839
Marketing category
BLA
Marketing start
2006-01-03
Marketing end
2027-12-31
Substance
MECASERMIN
Active strength
40 mg/4mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Increlex

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECASERMIN40 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7GR9I2683OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
604806Internal RxNorm lookup
615882Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8b27a1b-a611-4f91-ad22-76d4b390c3aeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-1040-5Increlex1 in 1 CARTONINJECTION, SOLUTION121
15054-1040-5Increlex4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-1040-5ML - Milliliter15054-1040172ec7e6-c297-485d-b8c7-cd31146cf79512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mecaserminACTIVE INGREDIENT7GR9I2683OINCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]10
mecaserminACTIVE MOIETY7GR9I2683OINCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]10
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHINCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]10
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHINCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]10
sodium acetateINACTIVE INGREDIENT4550K0SC9BINCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XINCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-1040INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20240322_a8b27a1b-a611-4f91-ad22-76d4b390c3ae.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IncrelexMECASERMINEton Pharmaceuticals, Inc.d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce2026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA021839
IncrelexMECASERMINIpsen Biopharmaceuticals, Inc.a8b27a1b-a611-4f91-ad22-76d4b390c3ae2025-08-05Warnings, Adverse reactionsExact identifier
application number: BLA021839
ndc (product): 15054-1040

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021839Increlexmecasermin351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
615882Increlex 10 MG/ML Injectable SolutionPSNa8b27a1b-a611-4f91-ad22-76d4b390c3ae21
604806mecasermin 10 MG/ML Injectable SolutionPSNa8b27a1b-a611-4f91-ad22-76d4b390c3ae21
615882mecasermin 10 MG/ML Injectable Solution [Increlex]SBDa8b27a1b-a611-4f91-ad22-76d4b390c3ae21
604806mecasermin 10 MG/ML Injectable SolutionSCDa8b27a1b-a611-4f91-ad22-76d4b390c3ae21
615882Increlex 10 MG/ML Injectable SolutionSYa8b27a1b-a611-4f91-ad22-76d4b390c3ae21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15054-1040-5150541040051 VIAL, MULTI-DOSE in 1 CARTON (15054-1040-5) / 4 mL in 1 VIAL, MULTI-DOSE2006-01-032027-12-31NoNoCurrent