hydrochlorothiazide

Generic: hydrochlorothiazide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrochlorothiazide
Generic Name hydrochlorothiazide
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-438
Product ID 46708-438_8ed60738-80b1-4c2d-a0f1-cf5fa17f8308
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200645
Listing Expiration 2026-12-31
Marketing Start 2017-03-02

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 46708438
Hyphenated Format 46708-438

Supplemental Identifiers

RxCUI
199903
UPC
0346708438302
UNII
0J48LPH2TH
NUI
N0000175359 N0000175419 M0471776

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 hydrochlorothiazide (source: ndc)
Generic Name hydrochlorothiazide (source: ndc)
Application Number ANDA200645 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (46708-438-10) / 10 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (46708-438-30)
  • 100 CAPSULE in 1 BOTTLE (46708-438-31)
  • 500 CAPSULE in 1 BOTTLE (46708-438-71)
  • 1000 CAPSULE in 1 BOTTLE (46708-438-91)
source: ndc

Packages (5)

46708-438-10 10 BLISTER PACK in 1 CARTON (46708-438-10) / 10 CAPSULE in 1 BLISTER PACK 46708-438-30 30 CAPSULE in 1 BOTTLE (46708-438-30) 46708-438-31 100 CAPSULE in 1 BOTTLE (46708-438-31) 46708-438-71 500 CAPSULE in 1 BOTTLE (46708-438-71) 46708-438-91 1000 CAPSULE in 1 BOTTLE (46708-438-91)

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": "8ed60738-80b1-4c2d-a0f1-cf5fa17f8308", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0346708438302"], "unii": ["0J48LPH2TH"], "rxcui": ["199903"], "spl_set_id": ["34703033-14c4-459c-8b8f-2f2e1145aff7"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (46708-438-10)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "46708-438-10", "marketing_start_date": "20170302"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-438-30)", "package_ndc": "46708-438-30", "marketing_start_date": "20170302"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-438-31)", "package_ndc": "46708-438-31", "marketing_start_date": "20170302"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (46708-438-71)", "package_ndc": "46708-438-71", "marketing_start_date": "20170302"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-438-91)", "package_ndc": "46708-438-91", "marketing_start_date": "20170302"}], "brand_name": "hydrochlorothiazide", "product_id": "46708-438_8ed60738-80b1-4c2d-a0f1-cf5fa17f8308", "dosage_form": "CAPSULE", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "46708-438", "generic_name": "Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA200645", "marketing_category": "ANDA", "marketing_start_date": "20170302", "listing_expiration_date": "20261231"}