Ibuprofen
- Product NDC
- 54348-836
- 11-digit product format
- 543480836
- Labeler code
- 54348
- Product ID
- 54348-836_eaa5d668-24d7-fd4a-e053-2995a90a3a52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Pharmpak, Inc.
- Application
- ANDA091239
- Marketing category
- ANDA
- Marketing start
- 2019-08-09
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54348-836-16 | 54348083616 | 1 BOTTLE in 1 BOX (54348-836-16) > 16 TABLET in 1 BOTTLE | 1 bottle | 2019-08-09 | 0000-00-00 | No | No | Current |