katerzia

Generic: amlodipine

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name katerzia
Generic Name amlodipine
Labeler azurity pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

amlodipine benzoate 1 mg/mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52652-5001
Product ID 52652-5001_461e8d10-1805-e107-e063-6294a90aa288
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211340
Listing Expiration 2026-12-31
Marketing Start 2019-08-15

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 526525001
Hyphenated Format 52652-5001

Supplemental Identifiers

RxCUI
2184120 2184126
UNII
XD75TQ8A2P

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 katerzia (source: ndc)
Generic Name amlodipine (source: ndc)
Application Number NDA211340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

52652-5001-1 1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE

Ingredients (1)

amlodipine benzoate (1 mg/mL)

Linked Drug Pages (1)

Katerzia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "461e8d10-1805-e107-e063-6294a90aa288", "openfda": {"unii": ["XD75TQ8A2P"], "rxcui": ["2184120", "2184126"], "spl_set_id": ["df673a4d-acb8-444c-a472-c87ab8cbd366"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52652-5001-1)  / 150 mL in 1 BOTTLE", "package_ndc": "52652-5001-1", "marketing_start_date": "20190815"}], "brand_name": "Katerzia", "product_id": "52652-5001_461e8d10-1805-e107-e063-6294a90aa288", "dosage_form": "SUSPENSION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "52652-5001", "generic_name": "Amlodipine", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Katerzia", "active_ingredients": [{"name": "AMLODIPINE BENZOATE", "strength": "1 mg/mL"}], "application_number": "NDA211340", "marketing_category": "NDA", "marketing_start_date": "20190815", "listing_expiration_date": "20261231"}