famotidine NDC 68475-400

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0400Add 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
68475-400-01	68475040001	50 mL in 1 BOTTLE, PLASTIC (68475-400-01)Marketed from Apr 22, 2021

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 — 40 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Navinta LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091020
Marketing start: Apr 22, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68475-400_12419fdc-7a4c-4762-806c-0d56b478ef9dSPL ID 12419fdc-7a4c-4762-806c-0d56b478ef9dSPL set ID 0f34a3be-7554-4040-b808-5ba8bf064abcRxCUI 310274UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468475040001 followed by a unit qualifier and the quantity

Package 68475-0400-01. 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 Sep 17, 2022.

Indications (excerpt from the label)

Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: peptic ulcer disease. GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091020

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

FDA NDC Directory listings under ANDA 091020
Product	Strength	Form · route	Labeler	Product NDC
Famotidine	Famotidine 40 mg/5mL	Powder, For suspensionOral	Zydus Pharmaceuticals USA Inc.	68382-444