FULVESTRANT
- Product NDC
- 70700-284
- 11-digit product format
- 707000284
- Labeler code
- 70700
- Product ID
- 70700-284_6c925fcb-edcf-fdff-d723-603f4227821b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Xiromed, LLC
- Application
- ANDA213553
- Marketing category
- ANDA
- Marketing start
- 2021-08-19
- 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 |
|---|
| 70700-284-98 | FULVESTRANT | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 4 |
| 70700-284-98 | FULVESTRANT | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-284 | FULVESTRANT INJECTION, SOLUTION [XIROMED, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230112_840cd7c0-9f33-f74e-f136-de7fe899bfb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70700-284-98 | 70700028498 | 2 SYRINGE, GLASS in 1 CARTON (70700-284-98) / 5 mL in 1 SYRINGE, GLASS | 2021-08-19 | 0000-00-00 | No | No | Current |