LEUPROLIDE ACETATE
- Product NDC
- 70710-1769
- 11-digit product format
- 707101769
- Labeler code
- 70710
- Product ID
- 70710-1769_fc662130-c2dd-4ff3-829b-9af6c52c5faf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUPROLIDE ACETATE
- Dosage form
- KIT
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA215826
- Marketing category
- ANDA
- Marketing start
- 2026-01-08
- 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 |
|---|---|
| Rxcui | 545835, 797544 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9e666f57-491f-16e0-fc75-cc1c9f2fe06f | Product name | 4 | 20250515 |
| 43944b95-6cc2-4eca-846a-a5e0ed070616 | Product name | 1 | 20240501 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| f3ff4518-37fe-47a0-8a1e-6ce032a3efd5 | Product name | 1 | 20230829 |
| 2ed2d111-4d16-4e2a-9b09-7d196056f6c9 | Product name | 1 | 20211214 |
| ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26 | Product name | 1 | 20200925 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 23ede539-308f-46e5-817b-41ef23af8d40 | Product name | 1 | 20150930 |
| 425e3610-bbe8-4d70-9c46-8cf09afc4e4d | Product name | 1 | 20150930 |
| ae18ed71-8057-40ec-987f-83624e50b906 | Product name | 1 | 20150122 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1768-1 | LEUPROLIDE ACETATE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 mg in 0.2mL | 6 | |
| 70710-1768-1 | LEUPROLIDE ACETATE | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 1 mg in 0.2mL | 6 |
| 70710-1769-3 | LEUPROLIDE ACETATE | 1 in 1 CARTON | KIT | 1 | 6 | |
| 70710-1897-8 | LEUPROLIDE ACETATE | 1 mL in 1 PACKET | SWAB | 1 mL | 0.7 mL in 1mL | 6 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 545835 | leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution | PSN | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 545835 | leuprolide acetate 5 MG/ML Injectable Solution | SCD | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
| 545835 | leuprolide acetate 1 MG per 0.2 ML Injectable Solution | SY | 35634415-000f-47db-9bd7-9e16eef3f02e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70710-1768-1 | 70710176801 | 1 in 1 CARTON | Historical | ||||
| 70710-1769-3 | 70710176903 | 1 KIT in 1 CARTON (70710-1769-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70710-1768-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70710-1897-8) | 1 kit | 2026-01-08 | No | No | Current |
| 70710-1897-8 | 70710189708 | 1 mL in 1 PACKET | 1 ml | Historical |