Ibuprofen And Famotidine NDC 80425-0384

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0384Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0384Add 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
80425-0384-1	80425038401	30 TABLET in 1 BOTTLE (80425-0384-1)Marketed from Apr 23, 2024
80425-0384-2	80425038402	60 TABLET in 1 BOTTLE (80425-0384-2)Marketed from Apr 23, 2024
80425-0384-3	80425038403	90 TABLET in 1 BOTTLE (80425-0384-3)Marketed from Apr 23, 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 Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216814
Marketing start: Apr 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 80425-0384_16c8a378-4a4c-885f-e063-6394a90acd4bSPL ID 16c8a378-4a4c-885f-e063-6394a90acd4bSPL set ID 16c8b0db-37d0-99d9-e063-6394a90ac31bRxCUI 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

N480425038401 followed by a unit qualifier and the quantity

Package 80425-0384-01. 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 Apr 23, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Ibuprofen and famotidine tablet, 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 tablet, a co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216814

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

FDA NDC Directory listings under ANDA 216814
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Ascent Pharmaceuticals, Inc.	43602-544
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	PHOENIX RX LLC	85509-1315
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-315