Fulvestrant
- Product NDC
- 0591-5019
- 11-digit product format
- 005915019
- Labeler code
- 0591
- Product ID
- 0591-5019_e9edcc92-8873-45a5-82bf-1dc564f67889
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA210063
- Marketing category
- NDA
- Marketing start
- 2019-08-22
- Marketing end
- 0000-00-00
- Substance
- FULVESTRANT
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-5019-02 | 00591501902 | 2 SYRINGE, GLASS in 1 CARTON (0591-5019-02) > 5 mL in 1 SYRINGE, GLASS (0591-5019-11) | 2019-08-22 | 0000-00-00 | No | No | Current |