NDC 49483-602 – Ibuprofen
Ibuprofen 400 mg/1 · Tablet, Film Coated · Oral
Product NDC49483-602
Product details
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Labeler
- TIME CAP LABORATORIES, INC
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA090796
- Marketed since
- December 30, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Active ingredients
- Ibuprofen 400 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 49483-602-01 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-602-01) | Dec 30, 2015 |
| 49483-602-50 | 500 TABLET, FILM COATED in 1 BOTTLE (49483-602-50) | Dec 30, 2015 |
Recalls mentioning this NDC
- D-0687-2018 May 2, 2018 · Class II
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0692-2018 May 2, 2018 · Class II
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0689-2018 May 2, 2018 · Class II
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-1055-2017 Aug 9, 2017 · Class II
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
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