Famotidine NDC 68788-8485

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8485Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8485Add 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
68788-8485-3	68788848503	30 TABLET, FILM COATED in 1 BOTTLE (68788-8485-3)Marketed from Jul 18, 2023
68788-8485-4	68788848504	14 TABLET, FILM COATED in 1 BOTTLE (68788-8485-4)Marketed from Jul 18, 2023
68788-8485-6	68788848506	60 TABLET, FILM COATED in 1 BOTTLE (68788-8485-6)Marketed from Jul 18, 2023
68788-8485-9	68788848509	90 TABLET, FILM COATED in 1 BOTTLE (68788-8485-9)Marketed from Jul 18, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215630
Marketing start: Jul 18, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68788-8485_70b50c77-9a69-4898-bfe2-813872788a4eSPL ID 70b50c77-9a69-4898-bfe2-813872788a4eSPL set ID b445a613-eaa8-45e8-be1f-5848bfd1dd36RxCUI 310273UNII 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

N468788848503 followed by a unit qualifier and the quantity

Package 68788-8485-03. 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 Apr 15, 2026.

Indications (excerpt from the label)

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater 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. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H2) receptor antagonist indicated (1) : In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215630

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

FDA NDC Directory listings under ANDA 215630
Product	Strength	Form · route	Labeler	Product NDC
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0091
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0092
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-843
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-842
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-889
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8518
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3829
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-713
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-712
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-345
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7982
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2442
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7981
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	NuCare Pharmceuticals,Inc.	68071-3413
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-843
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3420
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4574
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4084
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6582
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-453

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