Ganirelix Acetate
- Product NDC
- 0548-5001
- 11-digit product format
- 005485001
- Labeler code
- 0548
- Product ID
- 0548-5001_0e71b74d-723d-46a4-b2e5-7c7157949ad4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ganirelix Acetate
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- ANDA212613
- Marketing category
- ANDA
- Marketing start
- 2022-06-20
- 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 |
|---|
| 0548-5001-00 | Ganirelix Acetate | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 0548-5001-00 | Ganirelix Acetate | 0.5 mL in 1 SYRINGE | INJECTION | 0.5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0548-5001 | GANIRELIX ACETATE INJECTION [AMPHASTAR PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220620_9c286f64-8039-44ec-8fdd-d1a2f52b4c3c.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 |
|---|
| 0548-5001-00 | 00548500100 | 1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE | 1 syringe | 2022-06-20 | 0000-00-00 | No | No | Current |