diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 300 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-598
Product ID 68382-598_3683dc39-602e-463a-b04a-6d066d2fe94d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206534
Listing Expiration 2026-12-31
Marketing Start 2017-09-28

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382598
Hyphenated Format 68382-598

Supplemental Identifiers

RxCUI
830795 830801 830837 830845 830861
UNII
OLH94387TE

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diltiazem hydrochloride (source: ndc)
Generic Name diltiazem hydrochloride (source: ndc)
Application Number ANDA206534 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-06)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-16)
  • 10 BLISTER PACK in 1 CARTON (68382-598-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-598-30)
source: ndc

Packages (5)

68382-598-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-01) 68382-598-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-05) 68382-598-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-06) 68382-598-16 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-16) 68382-598-77 10 BLISTER PACK in 1 CARTON (68382-598-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-598-30)

Ingredients (1)

diltiazem hydrochloride (300 mg/1)

Linked Drug Pages (1)

diltiazem hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3683dc39-602e-463a-b04a-6d066d2fe94d", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830795", "830801", "830837", "830845", "830861"], "spl_set_id": ["1e2f2025-0350-40c4-ab42-3b57f3d105a6"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-01)", "package_ndc": "68382-598-01", "marketing_start_date": "20170928"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-05)", "package_ndc": "68382-598-05", "marketing_start_date": "20181002"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-06)", "package_ndc": "68382-598-06", "marketing_start_date": "20170928"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-598-16)", "package_ndc": "68382-598-16", "marketing_start_date": "20170928"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-598-77)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-598-30)", "package_ndc": "68382-598-77", "marketing_start_date": "20170928"}], "brand_name": "diltiazem hydrochloride", "product_id": "68382-598_3683dc39-602e-463a-b04a-6d066d2fe94d", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "68382-598", "generic_name": "diltiazem hydrochloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "diltiazem hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA206534", "marketing_category": "ANDA", "marketing_start_date": "20170928", "listing_expiration_date": "20261231"}