leuprolide acetate
- Product NDC
- 70121-2537
- 11-digit product format
- 701212537
- Labeler code
- 70121
- Product ID
- 70121-2537_9a91921e-6c03-429b-94b5-6d885f3fe364
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leuprolide acetate
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA215336
- Marketing category
- ANDA
- Marketing start
- 2022-11-07
- 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
- Listing expiration
- 2026-12-31
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 |
|---|
| 70121-1695-2 | leuprolide acetate | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 5 mg in 1mL | 9 |
| 70121-1695-2 | leuprolide acetate | 1 in 1 CARTON | INJECTION, SOLUTION | | 5 mg in 1mL | 9 |
| 70121-2537-6 | leuprolide acetate | 1 in 1 CARTON | KIT | 1 | | 9 |
| 70121-2538-9 | leuprolide acetate | 1 mL in 1 PACKET | SWAB | 28 mL | 0.7 mL in 1mL | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-2537 | LEUPROLIDE ACETATE KIT [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250427_4838c674-044e-46b2-81e7-c691b99d8fa5.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 |
|---|
| 70121-1695-2 | 70121169502 | 2.8 mL in 1 VIAL, MULTI-DOSE | 2.8 ml | | | | | Historical |
| 70121-2537-6 | 70121253706 | 1 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70121-2538-9) | 1 kit | 2022-11-07 | 0000-00-00 | No | No | Current |
| 70121-2538-9 | 70121253809 | 1 mL in 1 PACKET | 1 ml | | | | | Historical |