NDC 55513-005-01 - ARANESP

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 55513-005
Requested NDC: 55513-005-01
Package NDCs from labels: 55513-005-01, 55513-005-04
Manufacturer: Amgen, Inc | Amgen Manufacturing Limited LLC
Effective date: 2026-07-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ARANESP - Amgen, Inc \| Amgen Manufacturing Limited LLC	Amgen, Inc \| Amgen Manufacturing Limited LLC	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55513-005-01	ARANESP	1 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	1		159
55513-005-04	ARANESP	4 in 1 PACKAGE	SOLUTION	4		159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-005	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	157	Current NDC, Legacy NDC, 2 package rows	20240530_0fd36cb9-c4f6-4167-93c9-8530865db3f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-005-01	ML - Milliliter	55513-005	e43ab8a3-1ed9-48bb-8924-b28e59cf7733	1	2012-07-24
55513-005-04	ML - Milliliter	55513-005	2f5e95b4-3fc4-45a3-8a1a-ad1c15b39076	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DARBEPOETIN ALFA	ACTIVE INGREDIENT	15UQ94PT4P	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138
DARBEPOETIN ALFA	ACTIVE MOIETY	15UQ94PT4P	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138
WATER	INACTIVE INGREDIENT	059QF0KO0R	ARANESP (DARBEPOETIN ALFA) INJECTION, SOLUTION ARANESP (DARBEPOETIN ALFA) SOLUTION [AMGEN INC]	138

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 47 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier unii: 6OZP39ZG8H
Dr Talbots Infant Daily Allergy Relief	ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X	Talbot's Pharmaceuticals Family Products,LLC.	e8bdcc8a-c947-ff5d-e053-2a95a90a3b92	2022-09-12	Warnings	Exact identifier unii: 451W47IQ8X
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier unii: 6OZP39ZG8H
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	6a1322c7-7767-4569-aa22-9d2e36331283	2022-08-30	Warnings	Exact identifier unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape Flavor	ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR	Hyland's Consumer Health Inc.	e676dbb7-212f-47e3-e053-2995a90af4e1	2022-08-17	Warnings	Exact identifier unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape Flavor	ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR	Hyland's Consumer Health Inc.	e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d	2022-08-16	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMeds	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5b580-1d9f-3081-e053-2995a90a8031	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse Breathe	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5c313-046f-b0a7-e053-2a95a90a2a07	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	fad9615f-7004-415d-9f69-ee9ff95f0067	2022-07-12	Warnings	Exact identifier unii: 451W47IQ8X
BHI Constipation	DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED	MediNatura Inc	0365b75b-fee4-4c1d-89ab-c692bdd73f75	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier unii: 6OZP39ZG8H
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Fresenius Kabi USA, LLC	5bf47be3-f3fe-452b-8113-941796498345	2022-03-31	Warnings, Adverse reactions	Exact identifier unii: 22ADO53M6F unii: 593YOG76RN
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Wild Horse 777 Moisturizing Nasal	SODIUM CHLORIDE	Wild Horse 777, Inc.	b0b4dadd-11fa-3dbb-e053-2995a90a2097	2022-03-14	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.