IBUPROFEN
- Product NDC
- 43063-858
- 11-digit product format
- 430630858
- Labeler code
- 43063
- Product ID
- 43063-858_e6d84ece-235e-dcb3-e053-2995a90a234d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090796
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- 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 Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-858 | IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 24 | Legacy NDC | 20250112_eb2f349f-1731-4d1d-8218-fff6f6850091.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-858-01 | 43063085801 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-01) | 2019-05-03 | 0000-00-00 | No | No | Current |
| 43063-858-04 | 43063085804 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-04) | 2018-10-22 | 0000-00-00 | No | No | Current |
| 43063-858-06 | 43063085806 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-06) | 2019-01-04 | 0000-00-00 | No | No | Current |
| 43063-858-09 | 43063085809 | 9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-09) | 2019-06-20 | 0000-00-00 | No | No | Current |
| 43063-858-10 | 43063085810 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-10) | 2018-08-06 | 0000-00-00 | No | No | Current |
| 43063-858-12 | 43063085812 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-12) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-15 | 43063085815 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-15) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-18 | 43063085818 | 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-18) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-20 | 43063085820 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-20) | 2018-08-21 | 0000-00-00 | No | No | Current |
| 43063-858-21 | 43063085821 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-21) | 2018-07-20 | 0000-00-00 | No | No | Current |
| 43063-858-24 | 43063085824 | 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-24) | 2019-08-08 | 0000-00-00 | No | No | Current |
| 43063-858-28 | 43063085828 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-28) | 2019-09-24 | 0000-00-00 | No | No | Current |
| 43063-858-30 | 43063085830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-30) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-40 | 43063085840 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-40) | 2018-10-03 | 0000-00-00 | No | No | Current |
| 43063-858-60 | 43063085860 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-60) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-82 | 43063085882 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-82) | 2020-02-24 | 0000-00-00 | No | No | Current |
| 43063-858-90 | 43063085890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-90) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-93 | 43063085893 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-93) | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43063-858-94 | 43063085894 | 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-94) | 2018-06-08 | 0000-00-00 | No | No | Current |