ENFLONSIA

Product NDC: 0006-5073
11-digit product format: 000065073
Labeler code: 0006
Product ID: 0006-5073_3db80030-7b81-4686-872e-bd202c44ff24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLESROVIMAB
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Merck Sharp & Dohme LLC
Application: BLA761432
Marketing category: BLA
Marketing start: 2025-06-09
Substance: CLESROVIMAB
Active strength: 150 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ENFLONSIA	CLESROVIMAB	Merck Sharp & Dohme LLC	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	2025-06-20	Warnings, Adverse reactions	Exact identifier application number: BLA761432 ndc (product): 0006-5073

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLESROVIMAB	150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VJO29R4CP9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2716809	Internal RxNorm lookup
2716816	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
c9004a92-40e8-4cdb-b22d-d07929f8fc3b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0006-5073-01	ENFLONSIA	1 in 1 CARTON	INJECTION, SOLUTION	1	3
0006-5073-02	ENFLONSIA	10 in 1 CARTON	INJECTION, SOLUTION	10	3
0006-5073-99	ENFLONSIA	0.7 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.7	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-5073-01	ML - Milliliter	0006-5073	c506526f-a9f3-4e00-81f8-384038a9a68a	1	2025-07-08
0006-5073-02	ML - Milliliter	0006-5073	df5c8029-be32-42a7-9d09-84e1eb15bbbf	1	2025-07-08
0006-5073-99	ML - Milliliter	0006-5073	98c916aa-5f96-49fc-af2c-5800b38f7da0	1	2025-07-08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761432	Enflonsia	clesrovimab-cfor	351(a)	Rx	2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2716809	clesrovimab-cfor 105 MG in 0.7 ML Prefilled Syringe	PSN	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3
2716816	ENFLONSIA 105 MG in 0.7 ML Prefilled Syringe	PSN	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3
2716816	0.7 ML clesrovimab-cfor 150 MG/ML Prefilled Syringe [Enflonsia]	SBD	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3
2716809	0.7 ML clesrovimab-cfor 150 MG/ML Prefilled Syringe	SCD	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3
2716816	0.7 ML Enflonsia 150 MG/ML Prefilled Syringe	SY	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3
2716809	clesrovimab-cfor 105 MG per 0.7 ML Prefilled Syringe	SY	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3
2716816	Enflonsia 105 MG per 0.7 ML Prefilled Syringe	SY	c9004a92-40e8-4cdb-b22d-d07929f8fc3b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0006-5073-01	00006507301	1 SYRINGE, GLASS in 1 CARTON (0006-5073-01) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)		2025-06-09	No	No	Current
0006-5073-02	00006507302	10 SYRINGE, GLASS in 1 CARTON (0006-5073-02) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)		2025-06-09	No	No	Current
0006-5073-99	00006507399	0.7 mL in 1 SYRINGE, GLASS	0.7 ml				Historical