RETACRIT

Product NDC: 0069-1309
11-digit product format: 000691309
Labeler code: 0069
Product ID: 0069-1309_a2e74269-0093-454f-963e-35c7c2f4f1ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epoetin alfa-epbx
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: BLA125545
Marketing category: BLA
Marketing start: 2018-06-18
Substance: EPOETIN
Active strength: 40000 [iU]/mL
Pharmacologic classes: Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0069-1309	0069-1309-10	D	Discontinued by firm		2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RETACRIT	EPOETIN ALFA-EPBX	Vifor (International) Inc.	e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	2025-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125545
RETACRIT	EPOETIN ALFA-EPBX	Pfizer Laboratories Div Pfizer Inc	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	2025-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125545 ndc (product): 0069-1309

Additional Listing Data#

Finished product: Yes
Brand name base: RETACRIT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPOETIN	40000 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
64FS3BFH5W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2047591	Internal RxNorm lookup
2047596	Internal RxNorm lookup
2047600	Internal RxNorm lookup
2047602	Internal RxNorm lookup
2047606	Internal RxNorm lookup
2047608	Internal RxNorm lookup
2047612	Internal RxNorm lookup
2047614	Internal RxNorm lookup
2047621	Internal RxNorm lookup
2047623	Internal RxNorm lookup
2463731	Internal RxNorm lookup
2463733	Internal RxNorm lookup
2463735	Internal RxNorm lookup
2463737	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3af26b0d-8ad0-44e1-a538-8bdb5ab39374	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0069-1309-01	RETACRIT	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1	19
0069-1309-04	RETACRIT	4 in 1 CARTON	INJECTION, SOLUTION	4	19
0069-1309-10	RETACRIT	10 in 1 CARTON	INJECTION, SOLUTION	10	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-1309-01	ML - Milliliter	0069-1309	628edaf3-bb54-4b37-8424-3ab379cd5dd7	1	2018-06-11
0069-1309-04	ML - Milliliter	0069-1309	e2f4488d-e77e-4ada-b768-dd9096011ee7	1	2018-06-11
0069-1309-10	ML - Milliliter	0069-1309	64b5407f-e397-42b5-8d82-8ba11577d3b8	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-1309	RETACRIT (EPOETIN ALFA-EPBX) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	18	Current NDC, Legacy NDC, 3 package rows	20240621_3af26b0d-8ad0-44e1-a538-8bdb5ab39374.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125545	Retacrit	epoetin alfa-epbx	351(k) Biosimilar	Rx	2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2047591	epoetin alfa-epbx 10,000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463731	epoetin alfa-epbx 10,000 UNT/ML Injectable Solution	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463735	epoetin alfa-epbx 20,000 UNT/ML Injectable Solution	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047600	epoetin alfa-epbx 2000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047606	epoetin alfa-epbx 3000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047621	epoetin alfa-epbx 40,000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047612	epoetin alfa-epbx 4000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047596	Retacrit 10,000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463733	Retacrit 10,000 UNT/ML Injectable Solution	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463737	Retacrit 20,000 UNT/ML Injectable Solution	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047602	Retacrit 2000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047608	Retacrit 3000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047623	Retacrit 40,000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047614	Retacrit 4000 UNT in 1 ML Injection	PSN	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047596	1 ML epoetin alfa-epbx 10000 UNT/ML Injection [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047602	1 ML epoetin alfa-epbx 2000 UNT/ML Injection [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047608	1 ML epoetin alfa-epbx 3000 UNT/ML Injection [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047614	1 ML epoetin alfa-epbx 4000 UNT/ML Injection [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047623	1 ML epoetin alfa-epbx 40000 UNT/ML Injection [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463733	epoetin alfa-epbx 10000 UNT/ML Injectable Solution [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463737	epoetin alfa-epbx 20000 UNT/ML Injectable Solution [Retacrit]	SBD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047591	1 ML epoetin alfa-epbx 10000 UNT/ML Injection	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047600	1 ML epoetin alfa-epbx 2000 UNT/ML Injection	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047606	1 ML epoetin alfa-epbx 3000 UNT/ML Injection	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047612	1 ML epoetin alfa-epbx 4000 UNT/ML Injection	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047621	1 ML epoetin alfa-epbx 40000 UNT/ML Injection	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463731	epoetin alfa-epbx 10000 UNT/ML Injectable Solution	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463735	epoetin alfa-epbx 20000 UNT/ML Injectable Solution	SCD	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047591	1 ML EPO-epbx 10000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047596	1 ML EPO-epbx 10000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047600	1 ML EPO-epbx 2000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047602	1 ML EPO-epbx 2000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047606	1 ML EPO-epbx 3000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047608	1 ML EPO-epbx 3000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047612	1 ML EPO-epbx 4000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047614	1 ML EPO-epbx 4000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047621	1 ML EPO-epbx 40000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047623	1 ML EPO-epbx 40000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047591	1 ML ERYTHROPOIETIN-epbx 10000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047596	1 ML ERYTHROPOIETIN-epbx 10000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047600	1 ML ERYTHROPOIETIN-epbx 2000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047602	1 ML ERYTHROPOIETIN-epbx 2000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047606	1 ML ERYTHROPOIETIN-epbx 3000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047608	1 ML ERYTHROPOIETIN-epbx 3000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047612	1 ML ERYTHROPOIETIN-epbx 4000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047614	1 ML ERYTHROPOIETIN-epbx 4000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047621	1 ML ERYTHROPOIETIN-epbx 40000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047623	1 ML ERYTHROPOIETIN-epbx 40000 UNT/ML Injection [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047596	1 ML Retacrit 10000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047602	1 ML Retacrit 2000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047608	1 ML Retacrit 3000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047614	1 ML Retacrit 4000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047623	1 ML Retacrit 40000 UNT/ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463731	EPO-epbx 10000 UNT/ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463733	EPO-epbx 10000 UNT/ML Injectable Solution [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463735	EPO-epbx 20000 UNT/ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463737	EPO-epbx 20000 UNT/ML Injectable Solution [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047591	epoetin alfa-epbx 10,000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463731	epoetin alfa-epbx 20,000 UNT per 2 ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047600	epoetin alfa-epbx 2000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047606	epoetin alfa-epbx 3000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047621	epoetin alfa-epbx 40,000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047612	epoetin alfa-epbx 4000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463731	ERYTHROPOIETIN-epbx 10000 UNT/ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463733	ERYTHROPOIETIN-epbx 10000 UNT/ML Injectable Solution [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463735	ERYTHROPOIETIN-epbx 20000 UNT/ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463737	ERYTHROPOIETIN-epbx 20000 UNT/ML Injectable Solution [Retacrit]	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463733	Retacrit (epoetin alfa-epbx 20,000 UNT per 2 ML) Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047596	Retacrit 10,000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463733	Retacrit 10000 UNT/ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047602	Retacrit 2000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2463737	Retacrit 20000 UNT/ML Injectable Solution	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047608	Retacrit 3000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047623	Retacrit 40,000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19
2047614	Retacrit 4000 UNT per 1 ML Injection	SY	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-1309-01	00069130901	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
0069-1309-04	00069130904	4 VIAL, SINGLE-DOSE in 1 CARTON (0069-1309-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1309-01)		2018-06-18	0000-00-00	No	No	Current
0069-1309-10	00069130910	10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1309-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0069-1309-01)		2018-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RETACRIT	Pfizer Laboratories Div Pfizer Inc \| Hospira, Inc. \| Eurofins PROXY Laboratories B.V.	2025-06-22	HUMAN PRESCRIPTION DRUG LABEL	19