LEUPROLIDE ACETATE DEPOT
- Product NDC
- 69097-909
- 11-digit product format
- 690970909
- Labeler code
- 69097
- Product ID
- 69097-909_15d87847-b4c3-48bc-8c40-d8fc63fcb1b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leuprolide acetate
- Dosage form
- KIT
- Labeler
- CIPLA USA INC.
- Application
- NDA205054
- Marketing category
- NDA
- Marketing start
- 2022-07-15
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEUPROLIDE ACETATE DEPOT
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2606516 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-909-50 | LEUPROLIDE ACETATE DEPOT | 1 in 1 CARTON | KIT | 1 | | 5 |
| 69097-950-32 | LEUPROLIDE ACETATE DEPOT | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 2 mL | 22.5 mg in 2mL | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-909 | LEUPROLIDE ACETATE DEPOT (LEUPROLIDE ACETATE) KIT [CIPLA USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240831_1563a30b-66e0-445d-ba3e-1ccd5218133f.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 |
|---|
| 69097-909-50 | 69097090950 | 1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31) | 1 kit | 2022-07-15 | 0000-00-00 | No | No | Current |
| 69097-950-32 | 69097095032 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |