diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

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

diltiazem hydrochloride 120 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3484
Product ID 70518-3484_3a9d96fa-b59d-46cf-e063-6294a90a32df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208783
Listing Expiration 2026-12-31
Marketing Start 2022-08-19

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 705183484
Hyphenated Format 70518-3484

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
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-3484-0)
source: ndc

Packages (1)

70518-3484-0 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-3484-0)

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": "3a9d96fa-b59d-46cf-e063-6294a90a32df", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830861"], "spl_set_id": ["5e935265-d0fc-4223-835f-72426eeea6c4"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-3484-0)", "package_ndc": "70518-3484-0", "marketing_start_date": "20220819"}], "brand_name": "diltiazem hydrochloride", "product_id": "70518-3484_3a9d96fa-b59d-46cf-e063-6294a90a32df", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "70518-3484", "generic_name": "diltiazem hydrochloride", "labeler_name": "REMEDYREPACK 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": "20220819", "listing_expiration_date": "20261231"}