Combogesic
- Product NDC
- 68788-4009
- 11-digit product format
- 687884009
- Labeler code
- 68788
- Product ID
- 68788-4009_cd03b658-dba1-4a12-8f6f-ab00da499c05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETAMINOPHEN and IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- NDA209471
- Marketing category
- NDA
- Marketing start
- 2025-09-04
- Substance
- ACETAMINOPHEN; IBUPROFEN
- Active strength
- 325; 97.5 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Combogesic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| IBUPROFEN | 97.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, WK2XYI10QM |
| Rxcui | 2675760, 2675765 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-4009-1 | Combogesic | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-4009-1 | EA - Each | 68788-4009 | f37b4573-3230-443f-bd64-7b7ec4790bb4 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2675760 | acetaminophen 325 MG / ibuprofen 97.5 MG Oral Tablet | PSN | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675765 | combogesic 325 MG / 97.5 MG Oral Tablet | PSN | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675765 | acetaminophen 325 MG / ibuprofen 97.5 MG Oral Tablet [Combogesic] | SBD | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675760 | acetaminophen 325 MG / ibuprofen 97.5 MG Oral Tablet | SCD | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675760 | acetaminophen 325 MG / ibuprofen 97.5 MG Oral Tablet | SY | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675760 | APAP 325 MG / ibuprofen 97.5 MG Oral Tablet | SY | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675765 | APAP 325 MG / ibuprofen 97.5 MG Oral Tablet [Combogesic] | SY | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
| 2675765 | Combogesic 325 MG / 97.5 MG Oral Tablet | SY | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68788-4009-1 | 68788400901 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4009-1) | 2025-09-04 | No | No | Historical |