Ganirelix Acetate
- Product NDC
- 67184-0574
- 11-digit product format
- 671840574
- Labeler code
- 67184
- Product ID
- 67184-0574_edcb57c8-5b08-4076-b67c-93d6d610525d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ganirelix Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA218855
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- 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 |
|---|
| 67184-0574-1 | Ganirelix Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 67184-0574-1 | Ganirelix Acetate | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67184-0574-1 | 67184057401 | 1 BLISTER PACK in 1 CARTON (67184-0574-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 1 blister pack | 2025-05-15 | No | No | Current |