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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZL1R02VT79Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2612675Internal RxNorm lookup
2612681Internal RxNorm lookup
2612684Internal RxNorm lookup
2612687Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b383d74-4830-4587-95f7-c32a39268df7Available on FDA.report

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CIMERLIRANIBIZUMAB-EQRNCoherus BioSciences Ince0e23118-1490-a554-e053-2995a90ab90c2025-05-07Warnings, Adverse reactionsExact identifier
application number: BLA761165
CIMERLIRANIBIZUMAB-EQRNSandoz Inc4b383d74-4830-4587-95f7-c32a39268df72024-06-17Warnings, Adverse reactionsExact identifier
application number: BLA761165
ndc (product): 61314-625

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761165Cimerliranibizumab-eqrn351(k) InterchangeableRx2026-08-01

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-DOSE2024-12-12NoNoCurrent