FASLODEX
- Product NDC
- 0310-0720
- 11-digit product format
- 003100720
- Labeler code
- 0310
- Product ID
- 0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA021344
- Marketing category
- NDA
- Marketing start
- 2010-11-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FASLODEX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FULVESTRANT | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 22X328QOC4 |
| Rxcui | 727762, 727954 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-0720-10 | FASLODEX | 5 mL in 1 SYRINGE, GLASS | INJECTION | 5 | | 43 |
| 0310-0720-10 | FASLODEX | 2 in 1 CARTON | INJECTION | 2 | | 43 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-0720 | FASLODEX (FULVESTRANT) INJECTION [ASTRAZENECA PHARMACEUTICALS LP] | 40 | Current NDC, Legacy NDC, 2 package rows | 20240515_83d7a440-e904-4e36-afb5-cb02b1c919f7.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 |
|---|
| 0310-0720-10 | 00310072010 | 2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASS | 2010-11-01 | 0000-00-00 | No | No | Current |