leuprolide acetate
- Product NDC
- 72843-591
- 11-digit product format
- 728430591
- Labeler code
- 72843
- Product ID
- 72843-591_4e3665c7-c296-c3d1-e063-6294a90ada86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leuprolide acetate
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- UBI Pharma Inc.
- Application
- ANDA217957
- Marketing category
- ANDA
- Marketing start
- 2024-10-25
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- leuprolide acetate
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 545835, 797544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72843-590-01 | leuprolide acetate | 1 in 1 CARTON | INJECTION, SOLUTION | | 5 mg in 1mL | 6 |
| 72843-590-01 | leuprolide acetate | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 5 mg in 1mL | 6 |
| 72843-591-99 | leuprolide acetate | 1 in 1 CARTON | KIT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72843-591 | LEUPROLIDE ACETATE KIT [UBI PHARMA INC.] | 2 | Current NDC, 3 package rows | 20241027_cd46628f-055f-4da9-8c38-fa69af34eb4d.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 |
|---|
| 72843-590-01 | 72843059001 | 1 in 1 CARTON | | | | | Historical |
| 72843-591-99 | 72843059199 | 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET | 1 kit | 2024-10-25 | No | No | Current |