Prescription drug · NDA
Combogesic (Acetaminophen and ibuprofen) NDC 68788-4181
Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4181-1 | 6878841810168788418101 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4181-1)Marketed from Aug 20, 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)
- Combogesic
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Acetaminophen — 325 mg/1Ibuprofen — 97.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209471
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-4181_f3cee991-19ef-4a1c-bb14-cbc8b6f32776SPL ID f3cee991-19ef-4a1c-bb14-cbc8b6f32776SPL set ID f3cee991-19ef-4a1c-bb14-cbc8b6f32776RxCUI 2675760, 2675765UNII 362O9ITL9D, WK2XYI10QM
- Pharmacologic class
- 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
N468788418101followed by a unit qualifier and the quantityPackage 68788-4181-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
COMBOGESIC is indicated in adults for the short-term management of mild to moderate acute pain. COMBOGESIC is a combination of acetaminophen and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and is indicated in adults for the short term management of mild to moderate acute pain ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 68788-4181
- What is NDC 68788-4181?
- 68788-4181 is the product NDC for Combogesic, Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Combogesic (ACETAMINOPHEN and IBUPROFEN).
- What is the active ingredient?
- Acetaminophen, Ibuprofen.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Combogesic?
- 4 other product NDCs are listed under this name. See all Combogesic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Combogesic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4009 | 68788-4009-01 |
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc | 0143-9432 | 00143-9432-27 |
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3161 | 71335-3161-0171335-3161-0371335-3161-04 |
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | AFT Pharmaceuticals US, Inc. | 72260-129 | 72260-0129-0172260-0129-0272260-0129-16 |
Other NDCs under NDA 209471
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 |
|---|---|---|---|---|
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc | 0143-9432 |
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4009 |
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3161 |
| Combogesicacetaminophen and ibuprofen | Acetaminophen 325 mg/1; Ibuprofen 97.5 mg/1 | Tablet, Film coatedOral | AFT Pharmaceuticals US, Inc. | 72260-129 |