FULVESTRANT
- Product NDC
- 70771-1626
- 11-digit product format
- 707711626
- Labeler code
- 70771
- Product ID
- 70771-1626_6908877d-222b-43e6-a7e9-f264fae84be4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Zydus Lifesciences Limited
- 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 |
|---|
| 70771-1626-2 | FULVESTRANT | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 2 |
| 70771-1626-8 | FULVESTRANT | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1626 | FULVESTRANT INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221014_151b948a-3106-497a-b1c7-479307faeb89.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 |
|---|
| 70771-1626-2 | 70771162602 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |
| 70771-1626-8 | 70771162608 | 2 SYRINGE, GLASS in 1 CARTON (70771-1626-8) / 5 mL in 1 SYRINGE, GLASS (70771-1626-2) | | 2021-12-14 | 0000-00-00 | No | No | Current |