FDA.reportPublic FDA data

CIMERLI

Product NDC
61314-625
11-digit product format
613140625
Labeler code
61314
Product ID
61314-625_0bfab18c-289a-42a1-b426-0fc2274a7a3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranibizumab-eqrn
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Sandoz Inc
Application
BLA761165
Marketing category
BLA
Marketing start
2024-12-12
Substance
RANIBIZUMAB
Active strength
.5 mg/.05mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANIBIZUMAB.5 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
61314-625-94CIMERLI0.05 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.053
61314-625-94CIMERLI1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-625-94ML - Milliliter61314-6259cc22b48-5e24-4249-b8c3-4a572fe101d712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-625CIMERLI (RANIBIZUMAB-EQRN) INJECTION, SOLUTION [SANDOZ INC]2Current NDC, 2 package rows20241212_4b383d74-4830-4587-95f7-c32a39268df7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612681CIMERLI 0.3 MG in 0.05 ML InjectionPSN4b383d74-4830-4587-95f7-c32a39268df73
2612687CIMERLI 0.5 MG in 0.05 ML InjectionPSN4b383d74-4830-4587-95f7-c32a39268df73
2612675ranibizumab-eqrn 0.3 MG in 0.05 ML InjectionPSN4b383d74-4830-4587-95f7-c32a39268df73
2612684ranibizumab-eqrn 0.5 MG in 0.05 ML InjectionPSN4b383d74-4830-4587-95f7-c32a39268df73
26126870.05 ML ranibizumab-eqrn 10 MG/ML Injection [Cimerli]SBD4b383d74-4830-4587-95f7-c32a39268df73
26126810.05 ML ranibizumab-eqrn 6 MG/ML Injection [Cimerli]SBD4b383d74-4830-4587-95f7-c32a39268df73
26126840.05 ML ranibizumab-eqrn 10 MG/ML InjectionSCD4b383d74-4830-4587-95f7-c32a39268df73
26126750.05 ML ranibizumab-eqrn 6 MG/ML InjectionSCD4b383d74-4830-4587-95f7-c32a39268df73
2612681Cimerli 0.3 MG per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612687Cimerli 0.5 MG per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612687Cimerli 10 MG/ML per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612681Cimerli 6 MG/ML per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612675ranibizumab-eqrn 0.3 MG per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612684ranibizumab-eqrn 0.5 MG per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612684ranibizumab-eqrn 10 MG/ML per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73
2612675ranibizumab-eqrn 6 MG/ML per 0.05 ML InjectionSY4b383d74-4830-4587-95f7-c32a39268df73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61314-625-94613140625941 VIAL, SINGLE-DOSE in 1 CARTON (61314-625-94) / .05 mL in 1 VIAL, SINGLE-DOSE2024-12-12NoNoHistorical