Cetrorelix
- Product NDC
- 0480-5795
- 11-digit product format
- 004805795
- Labeler code
- 0480
- Product ID
- 0480-5795_f8c62e7c-4615-463b-af59-b820a9e3b911
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetrorelix Acetate
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA215737
- Marketing category
- ANDA
- Marketing start
- 2023-12-14
- Marketing end
- 2026-06-30
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetrorelix
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 283402 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-5795-08 | Cetrorelix | 1 in 1 CARTON | KIT | 1 | | 6 |
| 0480-5795-08 | Cetrorelix | 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 |
|---|
| 0480-5795 | CETRORELIX (CETRORELIX ACETATE) KIT [TEVA PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20240725_f91c971b-89d7-4306-966d-8ecc1afc16d1.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 |
|---|
| 0480-5795-08 | 00480579508 | 1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21) | 1 tray | 2023-12-14 | 2026-06-30 | No | No | Historical |