diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diltiazem hydrochloride 120 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-675
Product ID 47335-675_3c94f868-93d3-4b36-8420-b2903a0bd79a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090492
Listing Expiration 2026-12-31
Marketing Start 2011-10-31

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335675
Hyphenated Format 47335-675

Supplemental Identifiers

RxCUI
830795 830801 830837 830845 830861
UPC
0347335679830 0347335677836 0347335676839 0347335678833 0347335675832
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 ANDA090492 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-13)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-18)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-19)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-81)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-83)
source: ndc

Packages (5)

47335-675-13 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-13) 47335-675-18 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-18) 47335-675-19 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-19) 47335-675-81 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-81) 47335-675-83 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-83)

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": "3c94f868-93d3-4b36-8420-b2903a0bd79a", "openfda": {"upc": ["0347335679830", "0347335677836", "0347335676839", "0347335678833", "0347335675832"], "unii": ["OLH94387TE"], "rxcui": ["830795", "830801", "830837", "830845", "830861"], "spl_set_id": ["6f71ba5e-7bd6-409a-80c6-2f22d975aefc"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-13)", "package_ndc": "47335-675-13", "marketing_start_date": "20111031"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-18)", "package_ndc": "47335-675-18", "marketing_start_date": "20111031"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-19)", "package_ndc": "47335-675-19", "marketing_start_date": "20111031"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-81)", "package_ndc": "47335-675-81", "marketing_start_date": "20111031"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-83)", "package_ndc": "47335-675-83", "marketing_start_date": "20111031"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "47335-675_3c94f868-93d3-4b36-8420-b2903a0bd79a", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]"], "product_ndc": "47335-675", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA090492", "marketing_category": "ANDA", "marketing_start_date": "20111031", "listing_expiration_date": "20261231"}