FDA.reportPublic FDA data

Increlex

Product NDC
71863-216
11-digit product format
718630216
Labeler code
71863
Product ID
71863-216_52199e09-74a6-6144-e063-6294a90a59e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mecasermin
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Eton Pharmaceuticals, Inc.
Application
BLA021839
Marketing category
BLA
Marketing start
2025-04-16
Substance
MECASERMIN
Active strength
40 mg/4mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbceAvailable 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
71863-216-04Increlex4 mL in 1 VIAL, MULTI-DOSEINJECTION45
71863-216-04Increlex1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71863-216-04ML - Milliliter71863-2168155a745-94ae-40ea-86b2-89e36b31281012025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-216INCRELEX (MECASERMIN) INJECTION [ETON PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250508_d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce.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
ndc (product): 71863-216
IncrelexMECASERMINIpsen Biopharmaceuticals, Inc.a8b27a1b-a611-4f91-ad22-76d4b390c3ae2025-08-05Warnings, Adverse reactionsExact identifier
application number: BLA021839

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 SolutionPSNd5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce5
604806mecasermin 10 MG/ML Injectable SolutionPSNd5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce5
615882mecasermin 10 MG/ML Injectable Solution [Increlex]SBDd5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce5
604806mecasermin 10 MG/ML Injectable SolutionSCDd5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce5
615882Increlex 10 MG/ML Injectable SolutionSYd5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71863-216-04718630216041 VIAL, MULTI-DOSE in 1 CARTON (71863-216-04) / 4 mL in 1 VIAL, MULTI-DOSE2025-04-16NoNoCurrent