Ibuprofen and famotidine NDC 80425-0483

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0483Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0483Add 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
80425-0483-1	80425048301	30 TABLET in 1 BOTTLE (80425-0483-1)Marketed from Mar 22, 2024
80425-0483-2	80425048302	60 TABLET in 1 BOTTLE (80425-0483-2)Marketed from Mar 22, 2024
80425-0483-3	80425048303	90 TABLET in 1 BOTTLE (80425-0483-3)Marketed from Mar 22, 2024

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): Ibuprofen and famotidine
Generic name (nonproprietary): ibuprofen and famotidine
Active ingredients: Ibuprofen — 800 mg/1Famotidine — 26.6 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203658
Marketing start: Mar 22, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 80425-0483_2cf74136-002a-d2a4-e063-6294a90ae545SPL ID 2cf74136-002a-d2a4-e063-6294a90ae545SPL set ID 2cf7412a-7f94-e39f-e063-6294a90a5bc2RxCUI 1100066UNII WK2XYI10QM, 5QZO15J2Z8
Pharmacologic class: Histamine-2 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N480425048301 followed by a unit qualifier and the quantity

Package 80425-0483-01. 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 Jan 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )] . Ibuprofen and famotidine tablets…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203658

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

FDA NDC Directory listings under ANDA 203658
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Par Health USA, LLC	49884-366