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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FULVESTRANT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FULVESTRANT | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 22X328QOC4 |
| Rxcui | 727762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1688-2 | FULVESTRANT | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 3 |
| 70710-1688-8 | FULVESTRANT | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1688 | FULVESTRANT INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241208_994edf79-20a5-4e3a-bb35-c4fe3e65acba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1688-2 | 70710168802 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |
| 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 | 0000-00-00 | No | No | Current |