telmisartan and hydrochlorothiazide

Generic: telmisartan and hydrochlorothiazide

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

Drug Facts

Product Profile

Brand Name telmisartan and hydrochlorothiazide
Generic Name telmisartan and hydrochlorothiazide
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, telmisartan 80 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-211
Product ID 46708-211_7c37a82a-77c2-4d49-84ee-ee4f70b4ec93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203010
Listing Expiration 2026-12-31
Marketing Start 2014-03-14

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708211
Hyphenated Format 46708-211

Supplemental Identifiers

RxCUI
283316 283317 477130
UPC
0346708211301 0346708209308 0346708210304
UNII
0J48LPH2TH U5SYW473RQ
NUI
N0000175359 N0000175419 M0471776 N0000000070 N0000175561

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 telmisartan and hydrochlorothiazide (source: ndc)
Generic Name telmisartan and hydrochlorothiazide (source: ndc)
Application Number ANDA203010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (46708-211-10)
  • 30 TABLET in 1 BOTTLE (46708-211-30)
  • 1000 TABLET in 1 BOTTLE (46708-211-91)
source: ndc

Packages (3)

46708-211-10 100 TABLET in 1 CARTON (46708-211-10) 46708-211-30 30 TABLET in 1 BOTTLE (46708-211-30) 46708-211-91 1000 TABLET in 1 BOTTLE (46708-211-91)

Ingredients (2)

hydrochlorothiazide (25 mg/1) telmisartan (80 mg/1)

Linked Drug Pages (1)

Telmisartan and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7c37a82a-77c2-4d49-84ee-ee4f70b4ec93", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0346708211301", "0346708209308", "0346708210304"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130"], "spl_set_id": ["5b476740-e3f0-4f68-b07c-cd9eb2fa27ca"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (46708-211-10)", "package_ndc": "46708-211-10", "marketing_start_date": "20140314"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-211-30)", "package_ndc": "46708-211-30", "marketing_start_date": "20140314"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-211-91)", "package_ndc": "46708-211-91", "marketing_start_date": "20140314"}], "brand_name": "Telmisartan and Hydrochlorothiazide", "product_id": "46708-211_7c37a82a-77c2-4d49-84ee-ee4f70b4ec93", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "46708-211", "generic_name": "Telmisartan and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA203010", "marketing_category": "ANDA", "marketing_start_date": "20140314", "listing_expiration_date": "20261231"}