NDC 68462-562 – Diltiazem Hydrochloride
Diltiazem Hydrochloride 120 mg/1 · Capsule, Extended Release · Oral
Product NDC68462-562
Product details
- Brand name
- Diltiazem Hydrochloride
- Generic name
- Diltiazem Hydrochloride
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Dosage form
- Capsule, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA212317
- Marketed since
- March 22, 2021
- Listing expires
- December 31, 2027
- Pharmacologic class
- Calcium Channel Blocker
Active ingredients
- Diltiazem Hydrochloride 120 mg/1
Uses, dosage, side effects and warnings for Diltiazem Hydrochloride →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 68462-562-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-562-01) | Mar 22, 2021 |
Recalls mentioning this NDC
- D-0342-2025 Apr 16, 2025 · Class II
CGMP Deviations - D-0093-2025 Dec 11, 2024 · Class II
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. - D-0094-2025 Dec 11, 2024 · Class II
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. - D-0095-2025 Dec 11, 2024 · Class II
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. - D-0472-2024 May 1, 2024 · Class II
Failed Dissolution Specifications - D-0430-2024 Apr 10, 2024 · Class II
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
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