Prescription drug · BLA
Oxervate (cenegermin-bkbj) NDC 71981-020
Cenegermin 20 ug/mL · Solution/ drops · Ophthalmic · Domp farmaceutici S.p.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71981-020-07 | 71981002007 | 7 VIAL, MULTI-DOSE in 1 CARTON (71981-020-07) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Nov 26, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Oxervate
- Generic name (nonproprietary)
- cenegermin-bkbj
- Active ingredients
- Cenegermin — 20 ug/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Domp farmaceutici S.p.A.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761094
- Marketing start
- Listing expires
- Other FDA classes
- Nerve Growth Factor (Chemical structure)
- Identifiers
- Product ID 71981-020_2e8f7305-d061-417e-8506-a82e1546b5d8SPL ID 2e8f7305-d061-417e-8506-a82e1546b5d8SPL set ID 89e4bfec-d710-40ed-8885-5d13ba46b1cdRxCUI 2104336, 2104341UNII B6E7K36KT8
- Pharmacologic class
- Recombinant Human Nerve Growth Factor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471981002007followed by a unit qualifier and the quantityPackage 71981-0020-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761094
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Oxervatecenegermin-bkbj | — | Kit | Domp farmaceutici S.p.A. | 71981-001 |
- openFDA data updated
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