Ovidrel
- Product NDC
- 44087-1150
- 11-digit product format
- 440871150
- Labeler code
- 44087
- Product ID
- 44087-1150_59d39f88-54fb-480a-979b-4d3d2c7c2cd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- choriogonadotropin alfa
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- EMD Serono, Inc.
- Application
- BLA021149
- Marketing category
- BLA
- Marketing start
- 2003-10-06
- Substance
- CHORIOGONADOTROPIN ALFA
- Active strength
- 250 ug/.5mL
- Pharmacologic classes
- Gonadotropin [EPC], Gonadotropins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ovidrel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHORIOGONADOTROPIN ALFA | 250 ug/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6413W06WR3 |
| Rxcui | 727505, 727507 |
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 |
|---|
| 44087-1150-1 | Ovidrel | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | | 10 |
| 44087-1150-1 | Ovidrel | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CHORIOGONADOTROPIN ALFA | ACTIVE INGREDIENT | 6413W06WR3 | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| CHORIOGONADOTROPIN ALFA | ACTIVE MOIETY | 6413W06WR3 | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| METHIONINE | INACTIVE INGREDIENT | AE28F7PNPL | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44087-1150 | OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231228_a683e58a-63ea-44b8-a326-1a99a537bcf2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44087-1150-1 | 44087115001 | 1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) / .5 mL in 1 SYRINGE, GLASS | 2003-10-06 | 0000-00-00 | No | No | Current |