Fulvestrant
- Product NDC
- 0781-3492
- 11-digit product format
- 007813492
- Labeler code
- 0781
- Product ID
- 0781-3492_505df3f5-1119-4d76-969f-a0a2ededd51f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Sandoz Inc
- Application
- ANDA205935
- Marketing category
- ANDA
- Marketing start
- 2019-05-29
- Marketing end
- 0000-00-00
- Substance
- FULVESTRANT
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Estrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 0781-3492-12 | 00781349212 | 2 SYRINGE, GLASS in 1 CARTON (0781-3492-12) > 5 mL in 1 SYRINGE, GLASS (0781-3492-01) | 2020-03-26 | 0000-00-00 | No | No | Current |