Ibuprofen
- Product NDC
- 50383-584
- 11-digit product format
- 503830584
- Labeler code
- 50383
- Product ID
- 50383-584_b1ab5319-7dd9-4cc7-b34e-b9d8533a40b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA205647
- Marketing category
- ANDA
- Marketing start
- 2016-11-28
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- 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 |
|---|
| 50383-584-04 | 50383058404 | 1 BOTTLE in 1 CARTON (50383-584-04) > 118 mL in 1 BOTTLE | 1 bottle | 2016-11-28 | 0000-00-00 | No | No | Current |
| 50383-584-06 | 50383058406 | 4 TRAY in 1 CASE (50383-584-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-584-05) | 4 tray | 2016-11-28 | 0000-00-00 | No | No | Current |
| 50383-584-07 | 50383058407 | 10 TRAY in 1 CASE (50383-584-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-584-05) | 10 tray | 2016-11-28 | 0000-00-00 | No | No | Current |
| 50383-584-11 | 50383058411 | 4 TRAY in 1 CASE (50383-584-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-584-10) | 4 tray | 2016-11-28 | 0000-00-00 | No | No | Current |
| 50383-584-12 | 50383058412 | 10 TRAY in 1 CASE (50383-584-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-584-10) | 10 tray | 2016-11-28 | 0000-00-00 | No | No | Current |
| 50383-584-16 | 50383058416 | 473 mL in 1 BOTTLE (50383-584-16) | 473 ml | 2016-11-28 | 0000-00-00 | No | No | Current |