diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7870
Product ID 68788-7870_d15411d7-3140-41a5-8d97-c7cdc4443295
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208783
Listing Expiration 2026-12-31
Marketing Start 2021-02-15

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 687887870
Hyphenated Format 68788-7870

Supplemental Identifiers

RxCUI
830861
UNII
OLH94387TE

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 ANDA208783 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-1)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-3)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-6)
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-8)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-9)
source: ndc

Packages (5)

68788-7870-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-1) 68788-7870-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-3) 68788-7870-6 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-6) 68788-7870-8 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-8) 68788-7870-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-9)

Ingredients (1)

diltiazem hydrochloride (120 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": "d15411d7-3140-41a5-8d97-c7cdc4443295", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830861"], "spl_set_id": ["3d594530-885f-45c7-b8a5-fd7e503ff83f"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-1)", "package_ndc": "68788-7870-1", "marketing_start_date": "20210215"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-3)", "package_ndc": "68788-7870-3", "marketing_start_date": "20210215"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-6)", "package_ndc": "68788-7870-6", "marketing_start_date": "20210215"}, {"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-8)", "package_ndc": "68788-7870-8", "marketing_start_date": "20210215"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-9)", "package_ndc": "68788-7870-9", "marketing_start_date": "20210215"}], "brand_name": "diltiazem hydrochloride", "product_id": "68788-7870_d15411d7-3140-41a5-8d97-c7cdc4443295", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "68788-7870", "generic_name": "diltiazem hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "diltiazem hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA208783", "marketing_category": "ANDA", "marketing_start_date": "20210215", "listing_expiration_date": "20261231"}