FULVESTRANT
- Product NDC
- 16714-070
- 11-digit product format
- 167140070
- Labeler code
- 16714
- Product ID
- 16714-070_244e8f58-8aba-5ede-0b9d-a566f1021cfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Northstar Rx, LLC,
- Application
- ANDA213553
- Marketing category
- ANDA
- Marketing start
- 2021-08-23
- 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 |
|---|
| 16714-070-01 | FULVESTRANT | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 3 |
| 16714-070-02 | FULVESTRANT | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-070 | FULVESTRANT INJECTION, SOLUTION [NORTHSTAR RX, LLC, ] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230112_67566681-19b5-89df-2030-25df5b0cf641.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 |
|---|
| 16714-070-01 | 16714007001 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |
| 16714-070-02 | 16714007002 | 2 SYRINGE, GLASS in 1 CARTON (16714-070-02) / 5 mL in 1 SYRINGE, GLASS (16714-070-01) | | 2021-08-23 | 0000-00-00 | No | No | Current |