Ibuprofen
- Product NDC
- 58602-843
- 11-digit product format
- 586020843
- Labeler code
- 58602
- Product ID
- 58602-843_4a614548-3e17-4ead-97d2-634996a5b490
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA207753
- Marketing category
- ANDA
- Marketing start
- 2020-07-15
- Substance
- IBUPROFEN
- Active strength
- 200 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58602-843-12 | 58602084312 | 1 BOTTLE in 1 CARTON (58602-843-12) / 40 CAPSULE in 1 BOTTLE | 1 bottle | 2020-07-15 | No | No | Historical |
| 58602-843-18 | 58602084318 | 1 BOTTLE in 1 CARTON (58602-843-18) / 80 CAPSULE in 1 BOTTLE | 1 bottle | 2020-07-15 | No | No | Historical |
| 58602-843-30 | 58602084330 | 160 CAPSULE in 1 BOTTLE (58602-843-30) | 160 capsule | 2020-07-15 | No | No | Historical |
| 58602-843-32 | 58602084332 | 180 CAPSULE in 1 BOTTLE (58602-843-32) | 180 capsule | 2020-07-15 | No | No | Historical |
| 58602-843-34 | 58602084334 | 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-34) | 200 capsule | 2020-08-27 | No | No | Historical |
| 58602-843-38 | 58602084338 | 300 CAPSULE in 1 BOTTLE (58602-843-38) | 300 capsule | 2020-07-15 | No | No | Historical |
| 58602-843-70 | 58602084370 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC | | 2020-08-27 | No | No | Historical |
| 58602-843-72 | 58602084372 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC | | 2020-08-27 | No | No | Historical |
| 58602-843-73 | 58602084373 | 1 BOTTLE in 1 CARTON (58602-843-73) / 20 CAPSULE in 1 BOTTLE | 1 bottle | 2020-07-15 | No | No | Historical |
| 58602-843-74 | 58602084374 | 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-74) | 160 capsule | 2020-08-27 | No | No | Historical |
| 58602-843-75 | 58602084375 | 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-75) | 300 capsule | 2020-08-27 | No | No | Historical |
| 58602-843-79 | 58602084379 | 2 BOTTLE in 1 CARTON (58602-843-79) / 180 CAPSULE in 1 BOTTLE | 2 bottle | 2020-07-15 | No | No | Historical |
| 58602-843-92 | 58602084392 | 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-92) | 180 capsule | 2020-08-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen Capsules | Aurohealth LLC | APL HEALTHCARE LIMITED | 2022-05-16 | Human OTC Drug Label | 3 |