Prescription drug · ANDA
Ibuprofen and famotidine NDC 85509-1626
Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 · Tablet, Film coated · Oral · PHOENIX RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85509-1626-3 | 8550916260385509162603 | 30 TABLET, FILM COATED in 1 BOTTLE (85509-1626-3)Marketed from Apr 7, 2026 | |
| 85509-1626-6 | 8550916260685509162606 | 60 TABLET, FILM COATED in 1 BOTTLE (85509-1626-6)Marketed from Apr 7, 2026 | |
| 85509-1626-9 | 8550916260985509162609 | 90 TABLET, FILM COATED in 1 BOTTLE (85509-1626-9)Marketed from Apr 7, 2026 |
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, Film coated
- Route
- Oral
- Labeler
- PHOENIX RX LLCNDC labeler code 85509
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211890
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85509-1626_4ee3e858-3e4f-85de-e063-6394a90a21a0SPL ID 4ee3e858-3e4f-85de-e063-6394a90a21a0SPL set ID 4ee3e849-2197-8883-e063-6394a90a1748RxCUI 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
N485509162603followed by a unit qualifier and the quantityPackage 85509-1626-03. 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, …
Excerpt only. Read the full label for complete information.
About NDC 85509-1626
- What is NDC 85509-1626?
- 85509-1626 is the product NDC for Ibuprofen and famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, film coated, listed with the FDA by PHOENIX RX LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen and famotidine.
- What is the active ingredient?
- Ibuprofen, Famotidine.
- Who is the labeler?
- PHOENIX RX LLC, NDC labeler code 85509. 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 and famotidine?
- 18 other product NDCs are listed under this name. See all Ibuprofen and 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 and 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 and Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0587 | 80425-0587-0180425-0587-0280425-0587-03 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4580 | 70518-4580-00 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8897 | 68788-8897-09 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-908 | 59651-0908-90 |
| Ibuprofen and Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1924 | 70771-1924-09 |
| Ibuprofen and Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-214 | 72578-0214-16 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0422 | 80425-0422-0180425-0422-0280425-0422-03 |
| Ibuprofen And Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0384 | 80425-0384-0180425-0384-0280425-0384-03 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Par Health USA, LLC | 49884-366 | 49884-0366-09 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0483 | 80425-0483-0180425-0483-0280425-0483-03 |
Other NDCs under ANDA 211890
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 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8891 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-626 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8897 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Doc Rx | 69306-266 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4580 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-891 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0422 |
| Ibuprofen and famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1010 |
| Ibuprofen Famotidine | Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-641 |