hydrochlorothiazide

Generic: hydrochlorothiazide

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrochlorothiazide
Generic Name hydrochlorothiazide
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-404
Product ID 50268-404_47e556aa-a6c4-b2a6-e063-6294a90ac94a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203561
Listing Expiration 2027-12-31
Marketing Start 2022-12-08

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268404
Hyphenated Format 50268-404

Supplemental Identifiers

RxCUI
199903
UNII
0J48LPH2TH
NUI
N0000175359 N0000175419 M0471776

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 hydrochlorothiazide (source: ndc)
Generic Name hydrochlorothiazide (source: ndc)
Application Number ANDA203561 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-404-15) / 1 CAPSULE in 1 BLISTER PACK (50268-404-11)
source: ndc

Packages (1)

50268-404-15 50 BLISTER PACK in 1 BOX (50268-404-15) / 1 CAPSULE in 1 BLISTER PACK (50268-404-11)

Ingredients (1)

hydrochlorothiazide (12.5 mg/1)

Linked Drug Pages (1)

Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e556aa-a6c4-b2a6-e063-6294a90ac94a", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH"], "rxcui": ["199903"], "spl_set_id": ["ef56450d-86d3-2654-e053-2995a90a142c"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-404-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-404-11)", "package_ndc": "50268-404-15", "marketing_start_date": "20221208"}], "brand_name": "Hydrochlorothiazide", "product_id": "50268-404_47e556aa-a6c4-b2a6-e063-6294a90ac94a", "dosage_form": "CAPSULE", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "50268-404", "generic_name": "Hydrochlorothiazide", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA203561", "marketing_category": "ANDA", "marketing_start_date": "20221208", "listing_expiration_date": "20271231"}