Fulvestrant
- Product NDC
- 63323-715
- 11-digit product format
- 633230715
- Labeler code
- 63323
- Product ID
- 63323-715_c584c51e-3ce0-4682-a4dd-d0ac149201a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA210326
- Marketing category
- NDA
- Marketing start
- 2019-05-20
- 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 |
|---|
| 63323-715-01 | Fulvestrant | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 6 |
| 63323-715-05 | Fulvestrant | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-715 | FULVESTRANT (FULVESTRANT) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240308_fabe9bd8-ac23-4df1-a89a-223d5cd38914.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 |
|---|
| 63323-715-01 | 63323071501 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |
| 63323-715-05 | 63323071505 | 2 SYRINGE, GLASS in 1 CARTON (63323-715-05) / 5 mL in 1 SYRINGE, GLASS (63323-715-01) | | 2019-05-20 | 0000-00-00 | No | No | Current |