LEUPROLIDE ACETATE
- Product NDC
- 55150-478
- 11-digit product format
- 551500478
- Labeler code
- 55150
- Product ID
- 55150-478_25c69313-82c8-41fb-8bf5-13faf47519c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUPROLIDE ACETATE
- Dosage form
- KIT
- Labeler
- Eugia US LLC
- Application
- ANDA212963
- Marketing category
- ANDA
- Marketing start
- 2022-06-06
- 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 |
|---|
| 55150-338-01 | LEUPROLIDE ACETATE | 1 in 1 CARTON | INJECTION, SOLUTION | | 1 mg in 0.2mL | 6 |
| 55150-338-01 | LEUPROLIDE ACETATE | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 1 mg in 0.2mL | 6 |
| 55150-478-01 | LEUPROLIDE ACETATE | 1 in 1 CARTON | KIT | 1 | | 6 |
| 60913-006-01 | LEUPROLIDE ACETATE | 1 mL in 1 PACKET | SWAB | 28 mL | 0.7 mL in 1mL | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-478 | LEUPROLIDE ACETATE KIT [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241228_49a1d0c1-304c-46f2-a780-bd940ae1ced0.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 |
|---|
| 55150-338-01 | 55150033801 | 1 in 1 CARTON | | | | | | Historical |
| 55150-478-01 | 55150047801 | 1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (60913-006-01) | 1 kit | 2022-06-06 | 0000-00-00 | No | No | Current |
| 60913-006-01 | 60913000601 | 1 mL in 1 PACKET | 1 ml | | | | | Historical |