Fulvestrant
- Product NDC
- 55150-394
- 11-digit product format
- 551500394
- Labeler code
- 55150
- Product ID
- 55150-394_01fb9018-5093-40e6-bfea-83dee3a5ffc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA215169
- Marketing category
- ANDA
- Marketing start
- 2023-06-30
- 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 |
|---|
| 55150-394-02 | Fulvestrant | 5 mL in 1 SYRINGE | INJECTION | 5 | | 3 |
| 55150-394-02 | Fulvestrant | 2 in 1 CARTON | INJECTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-394 | FULVESTRANT INJECTION [EUGIA US LLC] | 2 | Current NDC, 2 package rows | 20230728_80b6dfe6-449d-4e2f-af90-bfbf9b04163b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-394-02 | 55150039402 | 2 SYRINGE in 1 CARTON (55150-394-02) / 5 mL in 1 SYRINGE | 2 syringe | 2023-06-30 | No | No | Historical |