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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXERVATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CENEGERMIN | 20 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B6E7K36KT8 |
| Rxcui | 2104336, 2104341 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71981-020-07 | OXERVATE | 1 mL in 1 VIAL, MULTI-DOSE | SOLUTION/ DROPS | 1 | | 14 |
| 71981-020-07 | OXERVATE | 7 in 1 CARTON | SOLUTION/ DROPS | 7 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71981-020 | OXERVATE (CENEGERMIN-BKBJ) SOLUTION/ DROPS OXERVATE (CENEGERMIN-BKBJ) KIT [DOMPÉ FARMACEUTICI S.P.A.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250212_89e4bfec-d710-40ed-8885-5d13ba46b1cd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71981-020-07 | 71981002007 | 7 VIAL, MULTI-DOSE in 1 CARTON (71981-020-07) / 1 mL in 1 VIAL, MULTI-DOSE | 2018-11-26 | 0000-00-00 | No | No | Current |