NDC 71981-020

OXERVATE

Cenegermin-bkbj

OXERVATE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Domp. The primary component is Cenegermin.

• Product ID: 71981-020_208e1798-eded-4339-8b33-78cc5cea9c2d
• NDC: 71981-020
• Product Type: Human Prescription Drug
• Proprietary Name: OXERVATE
• Generic Name: Cenegermin-bkbj
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-11-26
• Marketing Category: BLA / BLA
• Application Number: BLA761094
• Labeler Name: Domp
• Substance Name: CENEGERMIN
• Active Ingredient Strength: 20 ug/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71981-020-07

7 VIAL, MULTI-DOSE in 1 CARTON (71981-020-07) > 1 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2018-11-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71981-020-01 [71981002001]

OXERVATE SOLUTION/ DROPS

• Marketing Category: BLA
• Application Number: BLA761094
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-26
• Marketing End Date: 2019-11-22

NDC 71981-020-07 [71981002007]

OXERVATE SOLUTION/ DROPS

• Marketing Category: BLA
• Application Number: BLA761094
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-26

Drug Details

Active Ingredients

Ingredient	Strength
CENEGERMIN	20 ug/mL

OpenFDA Data

• SPL SET ID: 89e4bfec-d710-40ed-8885-5d13ba46b1cd
• Manufacturer:
  • Domp farmaceutici S.p.A.
• UNII:
  • B6E7K36KT8
• RxNorm Concept Unique ID - RxCUI:
  • 2104341
  • 2104336

NDC Crossover Matching brand name "OXERVATE" or generic name "Cenegermin-bkbj"

NDC	Brand Name	Generic Name
71981-001	OXERVATE	cenegermin-bkbj
71981-020	OXERVATE	cenegermin-bkbj