Ganirelix Acetate
- Product NDC
- 70748-274
- 11-digit product format
- 707480274
- Labeler code
- 70748
- Product ID
- 70748-274_c0fdd470-a16f-41c4-9bfa-4240b6ff67e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ganirelix Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA216075
- Marketing category
- ANDA
- Marketing start
- 2024-02-14
- Substance
- GANIRELIX ACETATE
- Active strength
- 250 ug/.5mL
- Pharmacologic classes
- Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ganirelix Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GANIRELIX ACETATE | 250 ug/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56U7906FQW |
| Rxcui | 855200 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70748-274-01 | Ganirelix Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 70748-274-01 | Ganirelix Acetate | 1 in 1 TRAY | INJECTION, SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-274 | GANIRELIX ACETATE INJECTION, SOLUTION [LUPIN PHARMACEUTICALS, INC.] | 7 | Current NDC, 2 package rows | 20250322_e50888ef-5e66-4b15-bdc3-2f6794f09246.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 |
|---|
| 70748-274-01 | 70748027401 | 1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS | 1 tray | 2024-02-14 | No | No | Current |