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

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

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
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

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	2026-08-01

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