Prescription drug · ANDA
Ibuprofen And Famotidine NDC 85509-1315
Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 · Tablet · Oral · PHOENIX RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85509-1315-3 | 85509131503 | 30 TABLET in 1 BOTTLE (85509-1315-3)Marketed from Sep 29, 2025 | |
| 85509-1315-6 | 85509131506 | 60 TABLET in 1 BOTTLE (85509-1315-6)Marketed from Sep 29, 2025 | |
| 85509-1315-9 | 85509131509 | 90 TABLET in 1 BOTTLE (85509-1315-9)Marketed from Sep 29, 2025 |
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
- PHOENIX RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216814
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85509-1315_3ff33409-9785-67bc-e063-6394a90ae2f3SPL ID 3ff33409-9785-67bc-e063-6394a90ae2f3SPL set ID 3ff33400-30e8-87fa-e063-6394a90a7f5cRxCUI 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
N485509131503followed by a unit qualifier and the quantityPackage 85509-1315-03. 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 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.
Other NDCs under ANDA 216814
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 | Ascent Pharmaceuticals, Inc. | 43602-544 |
| 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 |