Fulvestrant
- Product NDC
- 83634-203
- 11-digit product format
- 836340203
- Labeler code
- 83634
- Product ID
- 83634-203_6ecfd7da-f2b6-453d-8105-5f6e0bf5e95f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fulvestrant
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Avenacy, Inc.
- Application
- ANDA211422
- Marketing category
- ANDA
- Marketing start
- 2024-02-28
- 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 |
|---|
| 83634-203-41 | Fulvestrant | 5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 5 | | 1 |
| 83634-203-74 | Fulvestrant | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-203 | FULVESTRANT INJECTION, SOLUTION [AVENACY, INC.] | 1 | Current NDC, 2 package rows | 20240229_f44cffcc-8f5e-4a4c-a36e-ab946ce86266.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-203-41 | 83634020341 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | Historical |
| 83634-203-74 | 83634020374 | 2 SYRINGE, GLASS in 1 CARTON (83634-203-74) / 5 mL in 1 SYRINGE, GLASS (83634-203-41) | | 2024-02-28 | No | No | Current |