diltiazem hydrochloride 360 mg/1
diltiazem hydrochloride · CAPSULE, EXTENDED RELEASE · Zydus Pharmaceuticals (USA) Inc.
diltiazem hydrochloride is a capsule, extended release containing diltiazem hydrochloride at 360 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals (USA) Inc..
Key Facts
- Brand Name
- diltiazem hydrochloride
- Generic Name
- diltiazem hydrochloride
- NDC Code (Product)
68382-599- Manufacturer
- Zydus Pharmaceuticals (USA) Inc.
- Strength
- 360 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206534
- Marketing Start
- 09/28/2017
Recall History
Glenmark Pharmaceuticals Inc., USA
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Mckesson Packaging Services
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Glenmark Pharmaceuticals Inc., USA
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Teva Pharmaceuticals USA
GMP Deviation: lot not intended for commercial distribution.
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Teva Pharmaceuticals USA
Labelling: Incorrect Exp. Date
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Teva Pharmaceuticals USA Inc
Failed Dissolution Specifications: below specification limits for dissolution.
Frequently Asked Questions
What is diltiazem hydrochloride used for?
diltiazem hydrochloride contains diltiazem hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is diltiazem hydrochloride a controlled substance?
diltiazem hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for diltiazem hydrochloride?
The generic name for diltiazem hydrochloride is diltiazem hydrochloride. There are 12 other brand versions of diltiazem hydrochloride.
What is the NDC code for diltiazem hydrochloride 360 mg/1?
The NDC (National Drug Code) for diltiazem hydrochloride 360 mg/1 is 68382-599, listed by Zydus Pharmaceuticals (USA) Inc..
Other Diltiazem Brands
See all →- Diltiazem hydrochloride120 mg/172578-202
- Diltiazem Hydrochloride60 mg/10615-8033
- Diltiazem Hydrochloride240 mg/10904-7219
- DILTIAZEM HYDROCHLORIDE120 mg/116714-523
- Diltiazem Hydrochloride240 mg/116729-305
- Diltiazem Hydrochloride120 mg/124979-026
- Cardizem CD120 mg/10187-0795
- Cardizem LA360 mg/10187-2049
- TIAZAC EXTENDED RELEASE180 mg/10187-2613
- Diltiazem Hydrochloride120 mg/146708-725
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)