NDC 68382-921 – Entecavir
Entecavir 1 mg/1 · Tablet, Film Coated · Oral
Product NDC68382-921
Product details
- Brand name
- Entecavir
- Generic name
- Entecavir
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA206745
- Marketed since
- August 10, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Active ingredients
- Entecavir 1 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 68382-921-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01) | Aug 10, 2017 |
| 68382-921-06 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06) | Aug 10, 2017 |
| 68382-921-16 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16) | Aug 10, 2017 |
| 68382-921-77 | 10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30) | Aug 10, 2017 |
Recalls mentioning this NDC
- D-0001-2026 Oct 8, 2025 · Class II
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity - D-0002-2026 Oct 8, 2025 · Class II
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity - D-0657-2025 Sep 24, 2025 · Class II
Failed Impurity/Degradation Specifications - D-0656-2025 Sep 24, 2025 · Class II
Failed Impurity/Degradation Specifications
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