cetrorelix acetate
- Product NDC
- 68083-600
- 11-digit product format
- 680830600
- Labeler code
- 68083
- Product ID
- 68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cetrorelix acetate
- Dosage form
- KIT
- Labeler
- Gland Pharma Limited
- Application
- ANDA218150
- Marketing category
- ANDA
- Marketing start
- 2024-04-25
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- cetrorelix acetate
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 283402 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-600-01 | cetrorelix acetate | 1 in 1 CARTON | KIT | 1 | | 6 |
| 68083-600-01 | cetrorelix acetate | 1 in 1 TRAY | KIT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-600 | CETRORELIX ACETATE KIT [GLAND PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20240809_89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a.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 |
|---|
| 68083-600-01 | 68083060001 | 1 TRAY in 1 CARTON (68083-600-01) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01) | 1 tray | 2024-04-25 | No | No | Current |