Fensolvi
- Product NDC
- 62935-153
- 11-digit product format
- 629350153
- Labeler code
- 62935
- Product ID
- 62935-153_eeda0531-099b-4b55-b287-8c534c3bb5f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leuprolide Acetate
- Dosage form
- KIT
- Labeler
- TOLMAR Inc.
- Application
- NDA213150
- Marketing category
- NDA
- Marketing start
- 2020-06-03
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fensolvi
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 752884, 2371773 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62935-153-50 | Fensolvi | 1 in 1 CARTON | KIT | 1 | | 17 |
| 62935-154-50 | Fensolvi | 0.375 mL in 1 SYRINGE | INJECTION, SUSPENSION, EXTENDED | 0.375 mL | 45 mg in 0.375mL | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62935-153 | FENSOLVI (LEUPROLIDE ACETATE) KIT [TOLMAR INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20231206_dfb6e01c-f138-471d-bf5b-2be38247e3f0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62935-153-50 | 62935015350 | 1 KIT in 1 CARTON (62935-153-50) * .375 mL in 1 SYRINGE (62935-154-50) * .375 mL in 1 SYRINGE (62935-155-40) | 1 kit | 2020-06-03 | 0000-00-00 | No | No | Current |
| 62935-154-50 | 62935015450 | 0.375 mL in 1 SYRINGE | 0.375 ml | | | | | Historical |