Prescription drug · ANDA
Fulvestrant NDC 71731-6121
Fulvestrant 50 mg/mL · Injection · Intramuscular · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71731-6121-1 | 71731612101 | 2 SYRINGE, GLASS in 1 CARTON (71731-6121-1) / 5 mL in 1 SYRINGE, GLASSMarketed from Apr 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fulvestrant
- Generic name (nonproprietary)
- fulvestrant
- Active ingredients
- Fulvestrant — 50 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211422
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 71731-6121_6cfbb5fe-940b-4ff1-89a7-e1dfc42b235bSPL ID 6cfbb5fe-940b-4ff1-89a7-e1dfc42b235bSPL set ID 46086fe7-190d-4963-97bc-1fe22d36e6d2RxCUI 727762UNII 22X328QOC4
- Pharmacologic class
- Estrogen Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471731612101followed by a unit qualifier and the quantityPackage 71731-6121-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. ( 1 ) HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. ( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. ( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in combination with pal…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211422
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Avenacy, Inc. | 83634-203 |
| fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Sagent Pharmaceuticals | 25021-471 |
| fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Sagent Pharmaceuticals | 25021-471 |
| Fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Athenex Pharmaceutical Division, LLC. | 70860-211 |