Leuprolide Acetate
- Product NDC
- 83634-454
- 11-digit product format
- 836340454
- Labeler code
- 83634
- Product ID
- 83634-454_9ad77738-6d76-4efb-96af-e9848794b07a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leuprolide acetate
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- Avenacy, LLC
- Application
- ANDA217957
- Marketing category
- ANDA
- Marketing start
- 2025-03-15
- Marketing end
- 2026-06-30
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Leuprolide Acetate
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 |
|---|
| 83634-452-03 | Leuprolide Acetate | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 5 mg in 1mL | 3 |
| 83634-453-01 | Leuprolide Acetate | 1 mL in 1 PACKET | SWAB | 28 mL | 0.7 mL in 1mL | 3 |
| 83634-454-61 | Leuprolide Acetate | 1 in 1 CARTON | KIT | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-454 | LEUPROLIDE ACETATE KIT [AVENACY INC.] | 1 | Current NDC, 3 package rows | 20250316_15003c37-6e91-4c79-a85c-3d03343b53f9.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 |
|---|
| 83634-452-03 | 83634045203 | 2.8 mL in 1 VIAL, MULTI-DOSE | 2.8 ml | | | | | Historical |
| 83634-453-01 | 83634045301 | 1 mL in 1 PACKET | 1 ml | | | | | Historical |
| 83634-454-61 | 83634045461 | 1 KIT in 1 CARTON (83634-454-61) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03) * 1 mL in 1 PACKET (83634-453-01) | 1 kit | 2025-10-15 | 2026-06-30 | No | No | Historical |