NDC codes

FDA NDC Directory
Product NDC (as listed)0310-0720Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00310-0720Add 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 NDC11-digit (billing)PackageCopy
0310-0720-10003100720102 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASSMarketed from Nov 1, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Faslodex
Generic name (nonproprietary)
fulvestrant
Active ingredients
Fulvestrant — 50 mg/mL
Dosage form
Injection
Route
Intramuscular
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021344
Marketing start
Listing expires
Other FDA classes
Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
Identifiers
Product ID 0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2eSPL ID 9541dd80-09f9-4d3c-bb2a-fc354e198a2eSPL set ID 83d7a440-e904-4e36-afb5-cb02b1c919f7RxCUI 727762, 727954UNII 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

N400310072010 followed by a unit qualifier and the quantity

Package 00310-0720-10. 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 FASLODEX 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 FASLODEX 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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