Fulvestrant
- Product NDC
- 71731-6121
- 11-digit product format
- 717316121
- Labeler code
- 71731
- Product ID
- 71731-6121_6cfbb5fe-940b-4ff1-89a7-e1dfc42b235b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fulvestrant
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Application
- ANDA211422
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- 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 |
|---|
| 71731-6121-1 | Fulvestrant | 2 in 1 CARTON | INJECTION | 2 | | 6 |
| 71731-6121-1 | 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 |
|---|
| 71731-6121 | FULVESTRANT INJECTION [CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241230_46086fe7-190d-4963-97bc-1fe22d36e6d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71731-6121-1 | 71731612101 | 2 SYRINGE, GLASS in 1 CARTON (71731-6121-1) / 5 mL in 1 SYRINGE, GLASS | 2021-04-01 | 0000-00-00 | No | No | Current |