Ganirelix Acetate
- Product NDC
- 71288-554
- 11-digit product format
- 712880554
- Labeler code
- 71288
- Product ID
- 71288-554_fd318e79-614e-4c0e-a683-b465ab5b8386
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ganirelix Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA214996
- Marketing category
- ANDA
- Marketing start
- 2022-06-06
- 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 |
|---|
| 71288-554-80 | Ganirelix Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 71288-554-80 | Ganirelix Acetate | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-554 | GANIRELIX ACETATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250417_1f067dfb-f9c7-4020-ab7b-da2ba695ab32.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 |
|---|
| 71288-554-80 | 71288055480 | 1 BLISTER PACK in 1 CARTON (71288-554-80) / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS | 1 blister pack | 2022-06-06 | 0000-00-00 | No | No | Current |