GANIRELIX ACETATE
- Product NDC
- 68083-472
- 11-digit product format
- 680830472
- Labeler code
- 68083
- Product ID
- 68083-472_9d647fa7-adc3-4767-a8e5-1b44b07cdd34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GANIRELIX ACETATE
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215658
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- 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 |
|---|
| 68083-472-01 | GANIRELIX ACETATE | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 3 |
| 68083-472-01 | GANIRELIX ACETATE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-472 | GANIRELIX ACETATE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 2 package rows | 20231130_cad7c09c-234b-4e73-b460-a1b1f7adc28d.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 |
|---|
| 68083-472-01 | 68083047201 | 1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 1 blister pack | 2023-02-28 | No | No | Historical |