ketoconazole

Generic: ketoconazole

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-827
Product ID 64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210457
Listing Expiration 2027-12-31
Marketing Start 2018-06-26

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 3a5 inhibitors [moa] p-glycoprotein inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380827
Hyphenated Format 64380-827

Supplemental Identifiers

RxCUI
197853
UPC
0364380827061
UNII
R9400W927I
NUI
N0000175487 M0002083 N0000182141 N0000190115 N0000185503

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 ketoconazole (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number ANDA210457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64380-827-06)
  • 500 TABLET in 1 BOTTLE (64380-827-07)
source: ndc

Packages (2)

64380-827-06 100 TABLET in 1 BOTTLE (64380-827-06) 64380-827-07 500 TABLET in 1 BOTTLE (64380-827-07)

Ingredients (1)

ketoconazole (200 mg/1)

Linked Drug Pages (1)

KETOCONAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9781ff7c-39a7-4c61-a6ec-7f1947685c6b", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0364380827061"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["6d4be760-c723-4f54-a854-12c61cf91703"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-827-06)", "package_ndc": "64380-827-06", "marketing_start_date": "20180626"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64380-827-07)", "package_ndc": "64380-827-07", "marketing_start_date": "20180626"}], "brand_name": "KETOCONAZOLE", "product_id": "64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "64380-827", "generic_name": "KETOCONAZOLE", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOCONAZOLE", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA210457", "marketing_category": "ANDA", "marketing_start_date": "20180626", "listing_expiration_date": "20271231"}