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
IngredientStrength
CLESROVIMAB150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVJO29R4CP9
Rxcui2716809, 2716816

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5073-01ENFLONSIA1 in 1 CARTONINJECTION, SOLUTION13
0006-5073-02ENFLONSIA10 in 1 CARTONINJECTION, SOLUTION103
0006-5073-99ENFLONSIA0.7 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5073-01ML - Milliliter0006-5073c506526f-a9f3-4e00-81f8-384038a9a68a12025-07-08
0006-5073-02ML - Milliliter0006-5073df5c8029-be32-42a7-9d09-84e1eb15bbbf12025-07-08
0006-5073-99ML - Milliliter0006-507398c916aa-5f96-49fc-af2c-5800b38f7da012025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716809clesrovimab-cfor 105 MG in 0.7 ML Prefilled SyringePSNc9004a92-40e8-4cdb-b22d-d07929f8fc3b3
2716816ENFLONSIA 105 MG in 0.7 ML Prefilled SyringePSNc9004a92-40e8-4cdb-b22d-d07929f8fc3b3
27168160.7 ML clesrovimab-cfor 150 MG/ML Prefilled Syringe [Enflonsia]SBDc9004a92-40e8-4cdb-b22d-d07929f8fc3b3
27168090.7 ML clesrovimab-cfor 150 MG/ML Prefilled SyringeSCDc9004a92-40e8-4cdb-b22d-d07929f8fc3b3
27168160.7 ML Enflonsia 150 MG/ML Prefilled SyringeSYc9004a92-40e8-4cdb-b22d-d07929f8fc3b3
2716809clesrovimab-cfor 105 MG per 0.7 ML Prefilled SyringeSYc9004a92-40e8-4cdb-b22d-d07929f8fc3b3
2716816Enflonsia 105 MG per 0.7 ML Prefilled SyringeSYc9004a92-40e8-4cdb-b22d-d07929f8fc3b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0006-5073-01000065073011 SYRINGE, GLASS in 1 CARTON (0006-5073-01) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99) 2025-06-09NoNoHistorical
0006-5073-020000650730210 SYRINGE, GLASS in 1 CARTON (0006-5073-02) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99) 2025-06-09NoNoHistorical
0006-5073-99000065073990.7 mL in 1 SYRINGE, GLASS0.7 mlHistorical