FULVESTRANT
- Product NDC
- 70710-1688
- 11-digit product format
- 707101688
- Labeler code
- 70710
- Product ID
- 70710-1688_b2f2e6fc-229a-46a6-ad64-02e665f8e942
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA215234
- Marketing category
- ANDA
- Marketing start
- 2021-12-14
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 22X328QOC4 | FULVESTRANT | 129453-61-8 | FULVESTRANT |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1688-8 | 70710168808 | 2 SYRINGE, GLASS in 1 CARTON (70710-1688-8) / 5 mL in 1 SYRINGE, GLASS (70710-1688-2) | 2021-12-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| FULVESTRANT | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2024-08-20 | HUMAN PRESCRIPTION DRUG LABEL | 3 |