What is NDC 63323-715?

63323-715 is the product NDC for Fulvestrant, Fulvestrant 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fulvestrant NDC 63323-715 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-715Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0715Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63323-715-05	6332307150563323071505	2 SYRINGE, GLASS in 1 CARTON (63323-715-05) / 5 mL in 1 SYRINGE, GLASS (63323-715-01)Marketed from May 20, 2019

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: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210326
Marketing start: May 20, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 63323-715_c584c51e-3ce0-4682-a4dd-d0ac149201a8SPL ID c584c51e-3ce0-4682-a4dd-d0ac149201a8SPL set ID fabe9bd8-ac23-4df1-a89a-223d5cd38914RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N463323071505 followed by a unit qualifier and the quantity

Package 63323-0715-05. 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 Jan 31, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 63323-715

What is NDC 63323-715?: 63323-715 is the product NDC for Fulvestrant, Fulvestrant 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. 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?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fulvestrant NDCs
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	InjectionIntramuscular	BluePoint Laboratories.	68001-626	68001-0626-85
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

All 21 Fulvestrant NDCs