NDC 68382-255 – Oxybutynin
Oxybutynin Chloride 5 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC68382-255
Product details
- Brand name
- Oxybutynin
- Generic name
- Oxybutynin
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA202332
- Marketed since
- August 10, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- Cholinergic Muscarinic Antagonist
Active ingredients
- Oxybutynin Chloride 5 mg/1
Package NDC codes (6)
| Package NDC | Description | Since |
|---|---|---|
| 68382-255-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-01) | Aug 10, 2017 |
| 68382-255-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05) | Aug 10, 2017 |
| 68382-255-06 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06) | Aug 10, 2017 |
| 68382-255-14 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14) | Aug 10, 2017 |
| 68382-255-16 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16) | Aug 10, 2017 |
| 68382-255-77 | 10 BLISTER PACK in 1 CARTON (68382-255-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30) | Aug 10, 2017 |
Recalls mentioning this NDC
- D-0097-2024 Nov 15, 2023 · Class II
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - D-0098-2024 Nov 15, 2023 · Class II
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - D-0096-2024 Nov 15, 2023 · Class II
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - D-0038-2024 Oct 11, 2023 · Class II
Failed Dissolution Specifications
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- 70771-1087 Oxybutynin Chloride 10 mg/1 · Tablet, Film Coated, Extended Release · Zydus Lifesciences Limited
- 70771-1088 Oxybutynin Chloride 15 mg/1 · Tablet, Film Coated, Extended Release · Zydus Lifesciences Limited
- 68382-256 Oxybutynin Chloride 10 mg/1 · Tablet, Film Coated, Extended Release · Zydus Pharmaceuticals USA Inc.
- 68382-257 Oxybutynin Chloride 15 mg/1 · Tablet, Film Coated, Extended Release · Zydus Pharmaceuticals USA Inc.