diurex ultra

Generic: caffeine

Labeler: kobayashi healthcare international, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diurex ultra
Generic Name caffeine
Labeler kobayashi healthcare international, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

caffeine 100 mg/1

Manufacturer
Kobayashi Healthcare International, Inc.

Identifiers & Regulatory

Product NDC 52389-155
Product ID 52389-155_32c05c2a-5010-0362-e063-6394a90af7cf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M027
Listing Expiration 2026-12-31
Marketing Start 2005-09-01

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc] methylxanthine [epc]
Chemical Structure
xanthines [cs]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52389155
Hyphenated Format 52389-155

Supplemental Identifiers

RxCUI
308853
UPC
0072959550905
UNII
3G6A5W338E
NUI
N0000175739 N0000175729 N0000175790 M0023046

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 diurex ultra (source: ndc)
Generic Name caffeine (source: ndc)
Application Number M027 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 2 BOTTLE, PLASTIC in 1 PACKAGE (52389-155-02) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-155-80)
  • 1 BOTTLE in 1 CARTON (52389-155-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

52389-155-02 2 BOTTLE, PLASTIC in 1 PACKAGE (52389-155-02) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 52389-155-80 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-155-80) 52389-155-90 1 BOTTLE in 1 CARTON (52389-155-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

caffeine (100 mg/1)

Linked Drug Pages (1)

Diurex Ultra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32c05c2a-5010-0362-e063-6394a90af7cf", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0072959550905"], "unii": ["3G6A5W338E"], "rxcui": ["308853"], "spl_set_id": ["9a035265-40c6-43f5-8de6-6bece8449840"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["Kobayashi Healthcare International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PLASTIC in 1 PACKAGE (52389-155-02)  / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "52389-155-02", "marketing_start_date": "20240104"}, {"sample": false, "description": "80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-155-80)", "package_ndc": "52389-155-80", "marketing_start_date": "20050901"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (52389-155-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "52389-155-90", "marketing_start_date": "20050901"}], "brand_name": "Diurex Ultra", "product_id": "52389-155_32c05c2a-5010-0362-e063-6394a90af7cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "52389-155", "generic_name": "Caffeine", "labeler_name": "Kobayashi Healthcare International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diurex", "brand_name_suffix": "Ultra", "active_ingredients": [{"name": "CAFFEINE", "strength": "100 mg/1"}], "application_number": "M027", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20050901", "listing_expiration_date": "20261231"}