NDC 68462-190 – Naproxen
Naproxen 500 mg/1 · Tablet · Oral
Product NDC68462-190
Product details
- Brand name
- Naproxen
- Generic name
- Naproxen
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA078250
- Marketed since
- July 1, 2007
- Listing expires
- December 31, 2026
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Active ingredients
- Naproxen 500 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 68462-190-01 | 100 TABLET in 1 BOTTLE (68462-190-01) | Jul 1, 2007 |
| 68462-190-05 | 500 TABLET in 1 BOTTLE (68462-190-05) | Jul 1, 2007 |
| 68462-190-30 | 30 TABLET in 1 BOTTLE (68462-190-30) | Jul 1, 2007 |
| 68462-190-50 | 50 TABLET in 1 BOTTLE (68462-190-50) | Jul 1, 2007 |
Recalls mentioning this NDC
- D-0346-2025 Apr 16, 2025 · Class II
CGMP Deviations - D-0124-2024 Dec 6, 2023 · Class II
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen - D-0821-2021 Sep 29, 2021 · Class II
CGMP Deviations - D-0822-2021 Sep 29, 2021 · Class II
CGMP Deviations - D-1701-2012 Oct 3, 2012 · Class II
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Other Naproxen products
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- 50090-1583 Naproxen 375 mg/1 · Tablet · A-S Medication Solutions
- 50090-1584 Naproxen 375 mg/1 · Tablet · A-S Medication Solutions
- 50090-5645 Naproxen 500 mg/1 · Tablet · A-S Medication Solutions
- 50090-0482 Naproxen 500 mg/1 · Tablet · A-S Medication Solutions
- 50090-4636 Naproxen 375 mg/1 · Tablet · A-S Medication Solutions
- 50090-1585 Naproxen 375 mg/1 · Tablet · A-S Medication Solutions
- 50090-2788 Naproxen 250 mg/1 · Tablet · A-S Medication Solutions
- 50090-0483 Naproxen 500 mg/1 · Tablet · A-S Medication Solutions
- 50090-4752 Naproxen 250 mg/1 · Tablet · A-S Medication Solutions
- 50090-4637 Naproxen 375 mg/1 · Tablet · A-S Medication Solutions
- 50090-4638 Naproxen 375 mg/1 · Tablet · A-S Medication Solutions