KEPIVANCE
- Product NDC
- 66658-113
- 11-digit product format
- 666580113
- Labeler code
- 66658
- Product ID
- 66658-113_462812de-e664-609f-e063-6294a90a1e3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palifermin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Swedish Orphan Biovitrum AB (publ)
- Application
- BLA125103
- Marketing category
- BLA
- Marketing start
- 2023-08-04
- Substance
- PALIFERMIN
- Active strength
- 5.16 mg/1.2mL
- Pharmacologic classes
- Fibroblast Growth Factor 7 [CS], Increased Epithelial Proliferation [PE], Mucocutaneous Epithelial Cell 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
- KEPIVANCE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALIFERMIN | 5.16 mg/1.2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QMS40680K6 |
| Rxcui | 2643434, 2643436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66658-113-01 | KEPIVANCE | 1.2 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1.2 | | 22 |
| 66658-113-03 | KEPIVANCE | 3 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 3 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| palifermin | ACTIVE INGREDIENT | QMS40680K6 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| palifermin | ACTIVE MOIETY | QMS40680K6 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| histidine | INACTIVE INGREDIENT | 4QD397987E | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66658-113 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 21 | Current NDC, 2 package rows | 20241222_426f6e64-2c20-4a61-6d65-7320426f6e64.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66658-113-01 | 66658011301 | 1.2 mL in 1 VIAL, SINGLE-USE | 1.2 ml | | | | Historical |
| 66658-113-03 | 66658011303 | 3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01) | | 2023-08-04 | No | No | Current |