Fulvestrant
- Product NDC
- 68001-484
- 11-digit product format
- 680010484
- Labeler code
- 68001
- Product ID
- 68001-484_384e7b1e-9100-97cc-e063-6394a90afb72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- BluePoint Laboratories
- Application
- ANDA210044
- Marketing category
- ANDA
- Marketing start
- 2021-03-01
- Substance
- FULVESTRANT
- Active strength
- 250 mg/5mL
- 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 | 250 mg/5mL |
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 |
|---|
| 68001-484-85 | Fulvestrant | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 3 |
| 68001-484-86 | Fulvestrant | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-484 | FULVESTRANT INJECTION, SOLUTION [BLUEPOINT LABORATORIES] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241127_bc7b4eac-3b63-53d2-e053-2995a90ad5e7.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 |
|---|
| 68001-484-85 | 68001048485 | 2 SYRINGE, GLASS in 1 CARTON (68001-484-85) / 5 mL in 1 SYRINGE, GLASS (68001-484-86) | | 2021-03-01 | 0000-00-00 | No | No | Current |
| 68001-484-86 | 68001048486 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |