CAMCEVI
- Product NDC
- 69448-023
- 11-digit product format
- 694480023
- Labeler code
- 69448
- Product ID
- 69448-023_4b1ad850-61b1-d516-e063-6394a90aeea8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUPROLIDE
- Dosage form
- INJECTION, EMULSION
- Route
- SUBCUTANEOUS
- Labeler
- Accord BioPharma, Inc.
- Application
- NDA211488
- Marketing category
- NDA
- Marketing start
- 2025-05-19
- Substance
- LEUPROLIDE MESYLATE
- Active strength
- 42 mg/.37g
- Pharmacologic classes
- Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CAMCEVI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEUPROLIDE MESYLATE | 42 mg/.37g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8E3C3C493W |
| Rxcui | 2595044, 2595049 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69448-023-63 | CAMCEVI | 1 in 1 CARTON | INJECTION, EMULSION | 1 | | 8 |
| 69448-023-63 | CAMCEVI | 0.37 g in 1 SYRINGE | INJECTION, EMULSION | 0.37 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69448-023 | CAMCEVI (LEUPROLIDE) INJECTION, EMULSION [ACCORD BIOPHARMA, INC.] | 4 | Current NDC, 2 package rows | 20250520_cbff25e5-6fe8-4e44-b10a-8397b3349905.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 |
|---|
| 69448-023-63 | 69448002363 | 1 SYRINGE in 1 CARTON (69448-023-63) / .37 g in 1 SYRINGE | 1 syringe | 2025-05-19 | No | No | Current |