FDA.reportPublic FDA data

ARANESP

Product NDC
55513-003
11-digit product format
555130003
Labeler code
55513
Product ID
55513-003_7023e5d7-0f00-4fa4-8223-fa77bee46feb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
darbepoetin alfa
Dosage form
SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA103951
Marketing category
BLA
Marketing start
2006-09-11
Substance
DARBEPOETIN ALFA
Active strength
40 ug/mL
Pharmacologic classes
Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARBEPOETIN ALFA40 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15UQ94PT4PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 28 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349273Internal RxNorm lookup
349274Internal RxNorm lookup
349275Internal RxNorm lookup
349276Internal RxNorm lookup
352044Internal RxNorm lookup
352045Internal RxNorm lookup
352046Internal RxNorm lookup
352047Internal RxNorm lookup
730044Internal RxNorm lookup
730046Internal RxNorm lookup
731167Internal RxNorm lookup
731171Internal RxNorm lookup
731174Internal RxNorm lookup
731176Internal RxNorm lookup
731179Internal RxNorm lookup
731181Internal RxNorm lookup
731184Internal RxNorm lookup
731227Internal RxNorm lookup
731229Internal RxNorm lookup
731231Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fd36cb9-c4f6-4167-93c9-8530865db3f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-003-01ARANESP1 mL in 1 VIAL, SINGLE-DOSESOLUTION1159
55513-003-04ARANESP4 in 1 PACKAGESOLUTION4159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-003-01ML - Milliliter55513-00353ade314-a80c-42cf-beff-8c73b27fd6ad12012-07-24
55513-003-04ML - Milliliter55513-003ad5071de-53ca-4db2-8ef1-e96e273f71ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DARBEPOETIN ALFAACTIVE INGREDIENT15UQ94PT4PARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
DARBEPOETIN ALFAACTIVE MOIETY15UQ94PT4PARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138
WATERINACTIVE INGREDIENT059QF0KO0RARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]138

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-003ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]157Current NDC, Legacy NDC, 2 package rows20240530_0fd36cb9-c4f6-4167-93c9-8530865db3f9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARANESPDARBEPOETIN ALFAAmgen, Inc0fd36cb9-c4f6-4167-93c9-8530865db3f92026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103951
ndc (product): 55513-003

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103951Aranespdarbepoetin alpha351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605172Aranesp 10 MCG in 0.4 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
730046Aranesp 100 MCG in 0.5 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352047Aranesp 100 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731231Aranesp 150 MCG in 0.3 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731235Aranesp 200 MCG in 0.4 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
1654955Aranesp 200 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731245Aranesp 25 MCG in 0.42 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352044Aranesp 25 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731229Aranesp 300 MCG in 0.6 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731227Aranesp 40 MCG in 0.4 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352045Aranesp 40 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731241Aranesp 500 MCG in 1 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731250Aranesp 60 MCG in 0.3 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352046Aranesp 60 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731167darbepoetin alfa 0.06 MG in 0.3 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
1605171darbepoetin alfa 10 MCG in 0.4 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
730044darbepoetin alfa 100 MCG in 0.5 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
349276darbepoetin alfa 100 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731171darbepoetin alfa 150 MCG in 0.3 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731174darbepoetin alfa 200 MCG in 0.4 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
1654954darbepoetin alfa 200 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
349273darbepoetin alfa 25 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731179darbepoetin alfa 300 MCG in 0.6 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731181darbepoetin alfa 40 MCG in 0.4 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
349274darbepoetin alfa 40 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731184darbepoetin alfa 500 MCG in 1 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
349275darbepoetin alfa 60 MCG in 1 ML InjectionPSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731176darbopoetin alfa 25 MCG in 0.42 ML Prefilled SyringePSN0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312500.3 ML darbepoetin alfa 0.2 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312310.3 ML darbepoetin alfa 0.5 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
16051720.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312270.4 ML darbepoetin alfa 0.1 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312350.4 ML darbepoetin alfa 0.5 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312450.42 ML darbepoetin alfa 0.06 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7300460.5 ML darbepoetin alfa 0.2 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312290.6 ML darbepoetin alfa 0.5 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3520441 ML darbepoetin alfa 0.025 MG/ML Injection [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3520451 ML darbepoetin alfa 0.04 MG/ML Injection [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3520461 ML darbepoetin alfa 0.06 MG/ML Injection [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3520471 ML darbepoetin alfa 0.1 MG/ML Injection [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
16549551 ML darbepoetin alfa 0.2 MG/ML Injection [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312411 ML darbepoetin alfa 0.5 MG/ML Prefilled Syringe [Aranesp]SBD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311670.3 ML darbepoetin alfa 0.2 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311710.3 ML darbepoetin alfa 0.5 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
16051710.4 ML darbepoetin alfa 0.025 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311810.4 ML darbepoetin alfa 0.1 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311740.4 ML darbepoetin alfa 0.5 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311760.42 ML darbepoetin alfa 0.06 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7300440.5 ML darbepoetin alfa 0.2 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311790.6 ML darbepoetin alfa 0.5 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3492731 ML darbepoetin alfa 0.025 MG/ML InjectionSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3492741 ML darbepoetin alfa 0.04 MG/ML InjectionSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3492751 ML darbepoetin alfa 0.06 MG/ML InjectionSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
3492761 ML darbepoetin alfa 0.1 MG/ML InjectionSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
16549541 ML darbepoetin alfa 0.2 MG/ML InjectionSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7311841 ML darbepoetin alfa 0.5 MG/ML Prefilled SyringeSCD0fd36cb9-c4f6-4167-93c9-8530865db3f9159
16051720.4 ML Aranesp 0.025 MG/ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
7312450.42 ML Aranesp 0.06 MG/ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731227Aranesp 0.04 MG per 0.4 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731250Aranesp 0.06 MG per 0.3 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
730046Aranesp 0.1 MG per 0.5 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731231Aranesp 0.15 MG per 0.3 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731235Aranesp 0.2 MG per 0.4 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731229Aranesp 0.3 MG per 0.6 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731241Aranesp 0.5 MG per 1 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
1605172Aranesp 10 MCG per 0.4 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
730046Aranesp 100 MCG per 0.5 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352047Aranesp 100 MCG per 1 ML InjectionSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731231Aranesp 150 MCG per 0.3 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731235Aranesp 200 MCG per 0.4 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
1654955Aranesp 200 MCG per 1 ML InjectionSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352044Aranesp 25 MCG per 1 ML InjectionSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731245Aranesp 25 MCG/0.42 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731229Aranesp 300 MCG per 0.6 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731227Aranesp 40 MCG per 0.4 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352045Aranesp 40 MCG per 1 ML InjectionSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731241Aranesp 500 MCG per 1 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731250Aranesp 60 MCG per 0.3 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
352046Aranesp 60 MCG per 1 ML InjectionSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159
731181darbepoetin alfa 0.04 MG per 0.4 ML Prefilled SyringeSY0fd36cb9-c4f6-4167-93c9-8530865db3f9159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-003-01555130003011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
55513-003-04555130003044 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01) 2006-09-110000-00-00NoNoCurrent