Prescription drug · ANDA
Fulvestrant NDC 43598-262
Fulvestrant 50 mg/mL · Injection, Solution · Intramuscular · Dr.Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-262-23 | 43598026223 | 2 SYRINGE, GLASS in 1 CARTON (43598-262-23) / 5 mL in 1 SYRINGE, GLASS (43598-262-11)Marketed from Sep 5, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Solution
- Route
- Intramuscular
- Labeler
- Dr.Reddy's Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209246
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 43598-262_67af235f-7f8b-da5b-5eb6-91d0b20b2a9eSPL ID 67af235f-7f8b-da5b-5eb6-91d0b20b2a9eSPL set ID 2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682RxCUI 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
N443598026223followed by a unit qualifier and the quantityPackage 43598-0262-23. 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)
Monotherapy Fulvestrant is 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, or Combination Therapy Fulvestrant is indicated for the treatment of: 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. HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. Fulvestra…
Excerpt only. Read the full label for complete information.