OXERVATE

Product NDC
71981-001
11-digit product format
719810001
Labeler code
71981
Product ID
71981-001_a8f6e6a2-a76e-4e1b-b747-989811528a09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cenegermin-bkbj
Dosage form
KIT
Labeler
Domp� farmaceutici S.p.A.
Application
BLA761094
Marketing category
BLA
Marketing start
2018-11-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB6E7K36KT8
Rxcui2104336, 2104341

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
71981-001-01OXERVATE1 in 1 KITKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71981-001OXERVATE (CENEGERMIN-BKBJ) SOLUTION/ DROPS OXERVATE (CENEGERMIN-BKBJ) KIT [DOMPÉ FARMACEUTICI S.P.A.]14Current NDC, Legacy NDC, 1 package rows20250212_89e4bfec-d710-40ed-8885-5d13ba46b1cd.zip

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71981-001-01719810001011 KIT in 1 KIT (71981-001-01) * 7 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE1 kit2018-11-260000-00-00NoNoCurrent