FDA.reportPublic FDA data

CIMERLI

Product NDC
70114-440
Requested package NDC
70114-440-01
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 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
e0e23118-1490-a554-e053-2995a90ab90cAvailable 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
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

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
ndc (package): 70114-440-01
ndc (product): 70114-440
ndc11 (package): 70114044001
CIMERLIRANIBIZUMAB-EQRNSandoz Inc4b383d74-4830-4587-95f7-c32a39268df72024-06-17Warnings, Adverse reactionsExact identifier
application number: BLA761165

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761165Cimerliranibizumab-eqrn351(k) InterchangeableRx2026-06-01

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