Prescription drug · BLA
Oxervate (Cenegermin-bkbj) NDC 71981-001
Kit · Domp farmaceutici S.p.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71981-001-01 | 71981000101 | 1 KIT in 1 KIT (71981-001-01) * 7 VIAL, MULTI-DOSE in 1 CARTON / 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
- Dosage form
- Kit
- Labeler
- Domp farmaceutici S.p.A.NDC labeler code 71981
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761094
- Marketing start
- Listing expires
- Identifiers
- Product ID 71981-001_2e8f7305-d061-417e-8506-a82e1546b5d8SPL ID 2e8f7305-d061-417e-8506-a82e1546b5d8SPL set ID 89e4bfec-d710-40ed-8885-5d13ba46b1cdRxCUI 2104336, 2104341UNII B6E7K36KT8
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N471981000101followed by a unit qualifier and the quantityPackage 71981-0001-01. 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.
About NDC 71981-001
- What is NDC 71981-001?
- 71981-001 is the product NDC for Oxervate (cenegermin-bkbj) kit, listed with the FDA by Domp farmaceutici S.p.A.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxervate (Cenegermin-bkbj).
- Who is the labeler?
- Domp farmaceutici S.p.A., NDC labeler code 71981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxervate?
- 1 other product NDC are listed under this name. See all Oxervate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxervate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxervatecenegermin-bkbj | Cenegermin 20 ug/mL | Solution/ dropsOphthalmic | Domp farmaceutici S.p.A. | 71981-020 | 71981-0020-07 |
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 | Cenegermin 20 ug/mL | Solution/ dropsOphthalmic | Domp farmaceutici S.p.A. | 71981-020 |