Famotidine NDC 67457-448

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0448Add 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
67457-448-43	67457044843	10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00)Marketed from Jun 26, 2008

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): Famotidine
Generic name (nonproprietary): famotidine
Active ingredients: Famotidine — 10 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Mylan Institutional LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078641
Marketing start: Jun 26, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 67457-448_8845646e-1471-490d-a26b-f18c7e31a4c0SPL ID 8845646e-1471-490d-a26b-f18c7e31a4c0SPL set ID e3b13e23-122b-4bd4-95cf-b5a14b7afc05RxCUI 204441, 1743833UNII 5QZO15J2Z8
Pharmacologic class: Histamine-2 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

N467457044843 followed by a unit qualifier and the quantity

Package 67457-0448-43. 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 Jun 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: 1. Short term treatment of active duodenal ulcer . Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for period…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078641

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078641
Product	Strength	Form · route	Labeler	Product NDC
Famotidine	Famotidine 10 mg/mL	InjectionIntravenous	Mylan Institutional LLC	67457-457