Ibuprofen
- Product NDC
- 55700-446
- 11-digit product format
- 557000446
- Labeler code
- 55700
- Product ID
- 55700-446_c1af9352-c277-499c-9e24-ef955e0ac013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-446 | IBUPROFEN TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC] | 10 | Legacy NDC | 20241219_e9a5f214-a387-4429-a875-eb1e9aa714c1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-446-00 | 55700044600 | 100 TABLET, FILM COATED in 1 BOTTLE (55700-446-00) | 2016-10-17 | 0000-00-00 | No | No | Current |
| 55700-446-20 | 55700044620 | 20 TABLET, FILM COATED in 1 BOTTLE (55700-446-20) | 2016-10-17 | 0000-00-00 | No | No | Current |
| 55700-446-21 | 55700044621 | 21 TABLET, FILM COATED in 1 BOTTLE (55700-446-21) | 2016-10-17 | 0000-00-00 | No | No | Current |
| 55700-446-30 | 55700044630 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-446-30) | 2016-10-17 | 0000-00-00 | No | No | Current |
| 55700-446-60 | 55700044660 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-446-60) | 2016-10-17 | 0000-00-00 | No | No | Current |
| 55700-446-90 | 55700044690 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-446-90) | 2016-10-17 | 0000-00-00 | No | No | Current |