FULVESTRANT
- Product NDC
- 16729-436
- 11-digit product format
- 167290436
- Labeler code
- 16729
- Product ID
- 16729-436_3001d1ed-b200-7d1b-e063-6394a90ab45f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA211689
- Marketing category
- ANDA
- Marketing start
- 2021-01-21
- 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 |
|---|
| 16729-436-30 | FULVESTRANT | 2 in 1 CARTON | INJECTION | 2 | | 6 |
| 16729-436-31 | FULVESTRANT | 5 mL in 1 SYRINGE, GLASS | INJECTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-436 | FULVESTRANT INJECTION [ACCORD HEALTHCARE INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250312_b471eb51-488e-5312-e053-2a95a90a8116.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 |
|---|
| 16729-436-30 | 16729043630 | 2 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31) | | 2021-01-21 | 0000-00-00 | No | No | Current |
| 16729-436-31 | 16729043631 | 5 mL in 1 SYRINGE, GLASS | 5 ml | | | | | Historical |