FDA.reportPublic FDA data

ARANESP

Product NDC
55513-032
11-digit product format
555130032
Labeler code
55513
Product ID
55513-032_7023e5d7-0f00-4fa4-8223-fa77bee46feb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
darbepoetin alfa
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA103951
Marketing category
BLA
Marketing start
2006-06-07
Substance
DARBEPOETIN ALFA
Active strength
500 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 ALFA500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15UQ94PT4P
Rxcui349273, 349274, 349275, 349276, 352044, 352045, 352046, 352047, 730044, 730046, 731167, 731171, 731174, 731176, 731179, 731181, 731184, 731227, 731229, 731231

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
55513-032-01ARANESP1 in 1 BLISTER PACKINJECTION, SOLUTION1159
55513-032-01ARANESP1 in 1 PACKAGEINJECTION, SOLUTION1159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-032-01ML - Milliliter55513-032a5b25bf5-2125-4892-a377-8f156aceed2812012-07-24

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
55513-032ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]157Current NDC, Legacy NDC, 2 package rows20240530_0fd36cb9-c4f6-4167-93c9-8530865db3f9.zip

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
55513-032-01555130032011 BLISTER PACK in 1 PACKAGE (55513-032-01) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE1 blister pack2006-06-070000-00-00NoNoCurrent