NDC codes

FDA NDC Directory
Product NDC (as listed)80005-119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80005-0119Add 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
80005-119-168000501191650 mL in 1 BOTTLE (80005-119-16)Marketed from Aug 10, 2023

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217137
Marketing start
Listing expires
Other FDA classes
Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 80005-119_7753e6db-5fe8-4b35-8817-c50abda35144SPL ID 7753e6db-5fe8-4b35-8817-c50abda35144SPL set ID 45df5fae-b28a-4b48-95ef-96e4faad883fRxCUI 310274UNII 5QZO15J2Z8

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

N480005011916 followed by a unit qualifier and the quantity

Package 80005-0119-16. 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)

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 217137

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

FDA NDC Directory listings under ANDA 217137
ProductStrengthForm · routeLabelerProduct NDC
FamotidineFamotidine 40 mg/5mLPowder, For suspensionOralBiocon Pharma Inc.70377-113
FamotidineFamotidine 40 mg/5mLPowder, For suspensionOralBryant Ranch Prepack72162-2599
FamotidineFamotidine 40 mg/5mLPowder, For suspensionOralKesin Pharma Corporation81033-023

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in