FDA.reportPublic FDA data

CIMERLI

Product NDC
70114-440
11-digit product format
701140440
Labeler code
70114
Product ID
70114-440_4ce7246b-e546-412c-86c7-e23e3e215612
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranibizumab-eqrn
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Coherus BioSciences Inc
Application
BLA761165
Marketing category
BLA
Marketing start
2022-10-03
Marketing end
2027-01-31
Substance
RANIBIZUMAB
Active strength
.3 mg/.05mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CIMERLI

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANIBIZUMAB.3 mg/.05mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZL1R02VT79
Rxcui2612675, 2612681, 2612684, 2612687

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
02a7bcab-2730-41aa-8529-7c6226e65babProduct name120220516
d6b571bf-7bed-4e31-93c1-5553936e1c45Product name120220315
da4394b8-eff9-4932-92e2-14d8feb38640Product name120161208
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70114-440-01CIMERLI0.05 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0512
70114-440-01CIMERLI1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70114-440-01ML - Milliliter70114-4406f996b31-11fb-41aa-ad3d-591b27e61a2d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70114-440CIMERLI (RANIBIZUMAB-EQRN) INJECTION, SOLUTION [COHERUS BIOSCIENCES INC]12Current NDC, Legacy NDC, 2 package rows20250509_e0e23118-1490-a554-e053-2995a90ab90c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612681CIMERLI 0.3 MG in 0.05 ML InjectionPSNe0e23118-1490-a554-e053-2995a90ab90c12
2612687CIMERLI 0.5 MG in 0.05 ML InjectionPSNe0e23118-1490-a554-e053-2995a90ab90c12
2612675ranibizumab-eqrn 0.3 MG in 0.05 ML InjectionPSNe0e23118-1490-a554-e053-2995a90ab90c12
2612684ranibizumab-eqrn 0.5 MG in 0.05 ML InjectionPSNe0e23118-1490-a554-e053-2995a90ab90c12
26126870.05 ML ranibizumab-eqrn 10 MG/ML Injection [Cimerli]SBDe0e23118-1490-a554-e053-2995a90ab90c12
26126810.05 ML ranibizumab-eqrn 6 MG/ML Injection [Cimerli]SBDe0e23118-1490-a554-e053-2995a90ab90c12
26126840.05 ML ranibizumab-eqrn 10 MG/ML InjectionSCDe0e23118-1490-a554-e053-2995a90ab90c12
26126750.05 ML ranibizumab-eqrn 6 MG/ML InjectionSCDe0e23118-1490-a554-e053-2995a90ab90c12
2612681Cimerli 0.3 MG per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612687Cimerli 0.5 MG per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612687Cimerli 10 MG/ML per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612681Cimerli 6 MG/ML per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612675ranibizumab-eqrn 0.3 MG per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612684ranibizumab-eqrn 0.5 MG per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612684ranibizumab-eqrn 10 MG/ML per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12
2612675ranibizumab-eqrn 6 MG/ML per 0.05 ML InjectionSYe0e23118-1490-a554-e053-2995a90ab90c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70114-440-01701140440011 VIAL, SINGLE-DOSE in 1 CARTON (70114-440-01) / .05 mL in 1 VIAL, SINGLE-DOSE2022-10-032027-01-31NoNoCurrent