Fulvestrant
- Product NDC
- 68462-317
- 11-digit product format
- 684620317
- Labeler code
- 68462
- Product ID
- 68462-317_e98586b1-cab4-4f10-bf04-7e92f3ca2ff2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA207754
- Marketing category
- ANDA
- Marketing start
- 2019-08-22
- 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
- Fulvestrant
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-317-32 | Fulvestrant | 2 in 1 CARTON | INJECTION | 2 | | 8 |
| 68462-317-40 | Fulvestrant | 5 mL in 1 SYRINGE, GLASS | INJECTION | 5 | | 8 |
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 |
|---|
| 68462-317-32 | 68462031732 | 2 SYRINGE, GLASS in 1 CARTON (68462-317-32) / 5 mL in 1 SYRINGE, GLASS (68462-317-40) | | 2019-08-22 | 0000-00-00 | No | No | Current |
| 68462-317-40 | 68462031740 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |