LUTRATE DEPOT
- Product NDC
- 83831-134
- 11-digit product format
- 838310134
- Labeler code
- 83831
- Product ID
- 83831-134_d4332d30-8a83-4118-88bb-3c49851837b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leuprolide acetate
- Dosage form
- KIT
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA205054
- Marketing category
- NDA
- Marketing start
- 2025-03-26
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUTRATE DEPOT
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2606516, 2709448 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-134-01 | LUTRATE DEPOT | 1 in 1 CARTON | KIT | 1 | | 2 |
| 83831-150-22 | LUTRATE DEPOT | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 2 mL | 22.5 mg in 2mL | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83831-134 | LUTRATE DEPOT (LEUPROLIDE ACETATE) KIT [AVYXA PHARMA, LLC] | 1 | Current NDC, 2 package rows | 20250330_3a6d1373-17d9-4289-b62f-d299ffe55831.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 |
|---|
| 83831-134-01 | 83831013401 | 1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02) | 1 kit | 2025-03-26 | No | No | Current |
| 83831-150-22 | 83831015022 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | Historical |