Prescription drug · ANDA
Fulvestrant NDC 68001-626
Fulvestrant 50 mg/mL · Injection · Intramuscular · BluePoint Laboratories.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-626-85 | 6800106268568001062685 | 2 SYRINGE in 1 CARTON (68001-626-85) / 5 mL in 1 SYRINGE (68001-626-86)Marketed from Jan 17, 2025 |
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
- Route
- Intramuscular
- Labeler
- BluePoint Laboratories.NDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215077
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 68001-626_3ac255a1-c4ba-46f2-e063-6294a90a0628SPL ID 3ac255a1-c4ba-46f2-e063-6294a90a0628SPL set ID 57352662-d2fa-4dce-828f-4c51e46e0b4dRxCUI 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
N468001062685followed by a unit qualifier and the quantityPackage 68001-0626-85. 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 injection 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 HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy Fulvestrant injection 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 metasta…
Excerpt only. Read the full label for complete information.
About NDC 68001-626
- What is NDC 68001-626?
- 68001-626 is the product NDC for Fulvestrant, Fulvestrant 50 mg/mL injection, listed with the FDA by BluePoint Laboratories.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fulvestrant.
- What is the active ingredient?
- Fulvestrant.
- Who is the labeler?
- BluePoint Laboratories., NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fulvestrant?
- 20 other product NDCs are listed under this name. See all Fulvestrant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fulvestrant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Sagent Pharmaceuticals | 25021-471 | 25021-0471-66 |
| Fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Avenacy, Inc. | 83634-203 | 83634-0203-74 |
| Fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Dr.Reddy's Laboratories Inc | 43598-262 | 43598-0262-23 |
| Fulvestrant | Fulvestrant 50 mg/mL | InjectionIntramuscular | Sandoz Inc | 0781-3532 | 00781-3532-12 |
| Fulvestrant | Fulvestrant 50 mg/mL | InjectionIntramuscular | Sandoz Inc | 0781-9055 | 00781-9055-12 |
| Fulvestrant | Fulvestrant 50 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-394 | 55150-0394-02 |
| Fulvestrant | Fulvestrant 50 mg/mL | InjectionIntramuscular | Alembic Pharmaceuticals Inc. | 62332-650 | 62332-0650-10 |
| Fulvestrant | Fulvestrant 50 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9022 | 00143-9022-02 |
| Fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Zydus Pharmaceuticals USA Inc. | 70710-1688 | 70710-1688-08 |
| Fulvestrant | Fulvestrant 50 mg/mL | Injection, SolutionIntramuscular | Zydus Lifesciences Limited | 70771-1626 | 70771-1626-08 |
Other NDCs under ANDA 215077
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 | InjectionIntramuscular | Alembic Pharmaceuticals Inc. | 62332-650 |