What is NDC 68475-400?

68475-400 is the product NDC for famotidine, Famotidine 40 mg/5mL powder, for suspension, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Navinta LLC, NDC labeler code 68475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for famotidine?

252 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

famotidine NDC 68475-400 | National Drug Code

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	6847504000168475040001	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 LLCNDC labeler code 68475
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)

About NDC 68475-400

What is NDC 68475-400?: 68475-400 is the product NDC for famotidine, Famotidine 40 mg/5mL powder, for suspension, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: famotidine.
What is the active ingredient?: Famotidine.
Who is the labeler?: Navinta LLC, NDC labeler code 68475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for famotidine?: 252 other product NDCs are listed under this name. See all famotidine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other famotidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Famotidine	Famotidine 40 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	72603-564	72603-0564-01
Famotidine	Famotidine 40 mg/5mL	Powder, For suspensionOral	RISING PHARMA HOLDINGS, INC.	64980-737	64980-0737-50
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4144	68788-4144-0368788-4144-0468788-4144-06+1 more
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0589	80425-0589-0180425-0589-0280425-0589-03
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Family Dollar Stores, LLC	55319-057	55319-0057-1055319-0057-2555319-0057-50
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-030	87441-0030-01
Famotidine	Famotidine 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4119	68788-4119-0168788-4119-0368788-4119-04+3 more
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-150	48433-0150-20
Famotidine	Famotidine 20 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-4088	68788-4088-0368788-4088-0468788-4088-06+1 more
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4574	70518-4574-0070518-4574-0170518-4574-02+1 more

All 253 famotidine NDCs

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