diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

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

diltiazem hydrochloride 120 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6120
Product ID 0378-6120_17bfacaf-75db-4179-9a06-244e94a28554
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074910
Listing Expiration 2027-12-31
Marketing Start 1997-05-02

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 03786120
Hyphenated Format 0378-6120

Supplemental Identifiers

RxCUI
830865 830869 830872
UPC
0303786120017 0303786060016 0303786090013
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 ANDA074910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6120-01)
source: ndc

Packages (1)

0378-6120-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6120-01)

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": "17bfacaf-75db-4179-9a06-244e94a28554", "openfda": {"upc": ["0303786120017", "0303786060016", "0303786090013"], "unii": ["OLH94387TE"], "rxcui": ["830865", "830869", "830872"], "spl_set_id": ["ec7e93b8-666c-4d2f-8d08-07931e09f748"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6120-01)", "package_ndc": "0378-6120-01", "marketing_start_date": "19970502"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "0378-6120_17bfacaf-75db-4179-9a06-244e94a28554", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0378-6120", "generic_name": "diltiazem hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA074910", "marketing_category": "ANDA", "marketing_start_date": "19970502", "listing_expiration_date": "20271231"}