ibuprofen
- Product NDC
- 68788-8183
- 11-digit product format
- 687888183
- Labeler code
- 68788
- Product ID
- 68788-8183_b6a670e1-9a98-4742-b73c-b61105a07f5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8183-1 | 68788818301 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8183-1) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-2 | 68788818302 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8183-2) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-3 | 68788818303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8183-3) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-4 | 68788818304 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-8183-4) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-5 | 68788818305 | 50 TABLET, FILM COATED in 1 BOTTLE (68788-8183-5) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-6 | 68788818306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8183-6) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-7 | 68788818307 | 21 TABLET, FILM COATED in 1 BOTTLE (68788-8183-7) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-8 | 68788818308 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8183-8) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-9 | 68788818309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8183-9) | 2022-04-29 | 0000-00-00 | No | No | Current |