FDA.reportPublic FDA data

OXERVATE

Product NDC
71981-020
11-digit product format
719810020
Labeler code
71981
Product ID
71981-020_a8f6e6a2-a76e-4e1b-b747-989811528a09
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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-8885-5d13ba46b1cd2025-02-05Warnings, Adverse reactionsExact identifier
application number: BLA761094
ndc (product): 71981-020

Additional Listing Data#

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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761094Oxervatecenegermin-bkbj351(a)Rx2026-06-01

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