FDA.reportPublic FDA data

OXERVATE

Product NDC
71981-020
Requested package NDC
71981-020-07
11-digit product format
719810020
Labeler code
71981
Product ID
71981-020_2e8f7305-d061-417e-8506-a82e1546b5d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cenegermin-bkbj
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Domp� farmaceutici S.p.A.
Application
BLA761094
Marketing category
BLA
Marketing start
2018-11-26
Substance
CENEGERMIN
Active strength
20 ug/mL
Pharmacologic classes
Nerve Growth Factor [CS], Recombinant Human Nerve Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
OXERVATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CENEGERMIN20 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E7K36KT8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2104336Internal RxNorm lookup
2104341Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89e4bfec-d710-40ed-8885-5d13ba46b1cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
61b2228b-abbb-4dad-b9cf-6abab5d60d10Product name120181206
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71981-020-07OXERVATE1 mL in 1 VIAL, MULTI-DOSESOLUTION/ DROPS114
71981-020-07OXERVATE7 in 1 CARTONSOLUTION/ DROPS714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71981-020-07ML - Milliliter71981-020c47f2609-bad0-475a-9041-443f56a96e7712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71981-020OXERVATE (CENEGERMIN-BKBJ) SOLUTION/ DROPS OXERVATE (CENEGERMIN-BKBJ) KIT [DOMPÉ FARMACEUTICI S.P.A.]14Current NDC, Legacy NDC, 2 package rows20250212_89e4bfec-d710-40ed-8885-5d13ba46b1cd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXERVATECENEGERMIN-BKBJDomp farmaceutici S.p.A.89e4bfec-d710-40ed-8885-5d13ba46b1cd2024-12-31Warnings, Adverse reactionsExact identifier
application number: BLA761094
ndc (package): 71981-020-07
ndc (product): 71981-020
ndc11 (package): 71981002007

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761094Oxervatecenegermin-bkbj351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2104336cenegermin-bkbj 0.002 % Ophthamic SolutionPSN89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104341oxervate 0.002 % Ophthamic SolutionPSN89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104341cenegermin-bkbj 0.02 MG/ML Ophthalmic Solution [Oxervate]SBD89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104336cenegermin-bkbj 0.02 MG/ML Ophthalmic SolutionSCD89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104336cenegermin-bkbj 0.002 % Ophthamic SolutionSY89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104336cenegermin-bkbj 20 MCG/ML Ophthamic SolutionSY89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104341Oxervate 0.002 % Ophthamic SolutionSY89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104341Oxervate 0.02 MG/ML Ophthalmic SolutionSY89e4bfec-d710-40ed-8885-5d13ba46b1cd14
2104341Oxervate 20 MCG/ML Ophthalmic SolutionSY89e4bfec-d710-40ed-8885-5d13ba46b1cd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71981-020-07719810020077 VIAL, MULTI-DOSE in 1 CARTON (71981-020-07) / 1 mL in 1 VIAL, MULTI-DOSE2018-11-260000-00-00NoNoCurrent