FDA.reportPublic FDA data

Purified Cortrophin Gel

Product NDC
62559-861
11-digit product format
625590861
Labeler code
62559
Product ID
62559-861_acbfd15f-c384-4b64-b444-33952abc3566
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repository Corticotropin
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA008975
Marketing category
NDA
Marketing start
2025-02-28
Substance
CORTICOTROPIN
Active strength
80 [USP'U]/mL
Pharmacologic classes
Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Purified Cortrophin Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CORTICOTROPIN80 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK0U68Q2TXA
Rxcui309541, 2584475, 2685293, 2685298, 2707578, 2707580

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7Product name220250121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-861-11Purified Cortrophin Gel1 mL in 1 SYRINGE, GLASSINJECTION114
62559-861-11Purified Cortrophin Gel1 in 1 CARTONINJECTION114
62559-861-35Purified Cortrophin Gel0.5 mL in 1 SYRINGE, GLASSINJECTION0.514
62559-861-35Purified Cortrophin Gel1 in 1 CARTONINJECTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-861-11ML - Milliliter62559-861137cc9a4-aa31-4e98-a257-3a12dba0349d12025-05-14
62559-861-35ML - Milliliter62559-861d7e7ce7c-51bc-43ee-abae-d1581d216b9012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-861PURIFIED CORTROPHIN GEL (REPOSITORY CORTICOTROPIN) INJECTION [ANI PHARMACEUTICALS, INC.]12Current NDC, 4 package rows20250308_f27544ee-a0e2-4d84-b193-1c9efdf9e34c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685298corticotropin 40 UNT in 0.5 ML Prefilled Self-Controlled InjectorPSNf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2685293corticotropin 80 UNT in 1 ML Prefilled Self-Controlled InjectorPSNf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
309541corticotropin 80 UNT/ML Injectable SolutionPSNf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2707580Cortrophin 40 UNT in 0.5 ML Prefilled SyringePSNf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2707578Cortrophin 80 UNT in 1 ML Prefilled SyringePSNf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2584475CORTROPHIN 80 UNT/ML Injectable SolutionPSNf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
27075800.5 ML corticotropin 80 UNT/ML Prefilled Syringe [Cortrophin]SBDf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
27075781 ML corticotropin 80 UNT/ML Prefilled Syringe [Cortrophin]SBDf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2584475corticotropin 80 UNT/ML Injectable Solution [Cortrophin]SBDf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
26852980.5 ML corticotropin 80 UNT/ML Prefilled SyringeSCDf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
26852931 ML corticotropin 80 UNT/ML Prefilled SyringeSCDf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
309541corticotropin 80 UNT/ML Injectable SolutionSCDf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2685298corticotropin 40 UNT per 0.5 ML Prefilled Self-Controlled InjectorSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
309541corticotropin 400 UNT per 5 ML Injectable SolutionSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2685293corticotropin 80 UNT per 1 ML Prefilled Self-Controlled InjectorSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2707580Cortrophin 40 UNT per 0.5 ML Prefilled SyringeSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2584475Cortrophin 400 UNT per 5 ML Injectable SolutionSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2707578Cortrophin 80 UNT per 1 ML Prefilled SyringeSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14
2584475Cortrophin 80 UNT/ML Injectable SolutionSYf27544ee-a0e2-4d84-b193-1c9efdf9e34c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-861-11625590861111 SYRINGE, GLASS in 1 CARTON (62559-861-11) / 1 mL in 1 SYRINGE, GLASS2025-02-28NoNoHistorical
62559-861-35625590861351 SYRINGE, GLASS in 1 CARTON (62559-861-35) / .5 mL in 1 SYRINGE, GLASS2025-02-28NoNoHistorical