Prescription drug · ANDA
Ibuprofen Famotidine NDC 72189-667
Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-667-90 | 7218906679072189066790 | 90 TABLET in 1 BOTTLE (72189-667-90)Marketed from Jun 22, 2026 |
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 Famotidine
- Generic name (nonproprietary)
- ibuprofen famotidine
- Active ingredients
- Ibuprofen — 800 mg/1Famotidine — 26.6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218684
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72189-667_54d9e1fc-507e-1859-e063-6394a90a8c6bSPL ID 54d9e1fc-507e-1859-e063-6394a90a8c6bSPL set ID 54d9e1fc-507d-1859-e063-6394a90a8c6bRxCUI 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
N472189066790followed by a unit qualifier and the quantityPackage 72189-0667-90. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H2-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)].
Excerpt only. Read the full label for complete information.
About NDC 72189-667
- What is NDC 72189-667?
- 72189-667 is the product NDC for Ibuprofen Famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen Famotidine.
- What is the active ingredient?
- Ibuprofen, Famotidine.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen Famotidine?
- 1 other product NDC are listed under this name. See all Ibuprofen Famotidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen Famotidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-641 | 72189-0641-90 |
Other NDCs under ANDA 218684
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ibuprofen and Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1924 |
| Ibuprofen and Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-214 |
| Ibuprofen and Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0587 |