GONAL-F RFF
- Product NDC
- 44087-9005
- 11-digit product format
- 440879005
- Labeler code
- 44087
- Product ID
- 44087-9005_74b90b4d-0b84-4185-aff6-4b5d58ad8555
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- follitropin alfa
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- EMD Serono, Inc.
- Application
- BLA021765
- Marketing category
- BLA
- Marketing start
- 2004-03-25
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FOLLITROPIN | ACTIVE INGREDIENT | 076WHW89TW | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
| FOLLITROPIN | ACTIVE MOIETY | 076WHW89TW | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
| METHIONINE | INACTIVE INGREDIENT | AE28F7PNPL | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44087-9005 | GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] | 15 | Legacy NDC | 20231124_aa759a1b-2c1d-438b-bd7e-019a2067699d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44087-9005-1 | 44087900501 | 1 BLISTER PACK in 1 CARTON (44087-9005-1) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS (44087-9998-1) | 1 blister pack | 2004-03-25 | 0000-00-00 | No | No | Current |
| 44087-9005-6 | 44087900506 | 10 BLISTER PACK in 1 CARTON (44087-9005-6) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS (44087-9998-1) | 10 blister pack | 2004-03-25 | 0000-00-00 | No | No | Current |