Ibuprofen And Famotidine NDC 43602-544

NDC codes

FDA NDC Directory

Product NDC (as listed)43602-544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43602-0544Add 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
43602-544-05	43602054405	500 TABLET in 1 BOTTLE (43602-544-05)Marketed from Oct 6, 2022
43602-544-30	43602054430	30 TABLET in 1 BOTTLE (43602-544-30)Marketed from Oct 6, 2022
43602-544-90	43602054490	90 TABLET in 1 BOTTLE (43602-544-90)Marketed from Oct 6, 2022

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): 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: Ascent Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216814
Marketing start: Oct 6, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689SPL ID 97d403fb-8a67-483d-8f9c-45dd16a31689SPL set ID 03733e49-7db4-4d98-b363-d0d23686ec72UNII WK2XYI10QM, 5QZO15J2Z8UPC 0343602544306
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

N443602054405 followed by a unit qualifier and the quantity

Package 43602-0544-05. 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 Mar 15, 2023. 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	PHOENIX RX LLC	85509-1315
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-315
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0384