telmisartan and hydrochlorothiazide (68180-194)

Drug Facts

Product Profile

Brand Name telmisartan and hydrochlorothiazide

Generic Name telmisartan and hydrochlorothiazide

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, telmisartan 80 mg/1

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-194

Product ID 68180-194_92888a3c-daab-4cd1-b883-6ecbe682faa9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091351

Listing Expiration 2027-12-31

Marketing Start 2014-08-07

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 68180194

Hyphenated Format 68180-194

Supplemental Identifiers

RxCUI

283316 283317 477130

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 ANDA091351 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
80 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan and Hydrochlorothiazide Tablets USP are available in three strengths: 40 mg/12.5 mg: supplied as oval shaped, biconvex, bilayer, uncoated tablets; where hydrochlorothiazide layer is red coloured and telmisartan layer is white to off-white in colour but may have red specks; debossed with 'M31' on one side and 'LU' on other side. Bottle of 30's: NDC 68180-193-06 Bottle of 90's: NDC 68180-193-09 Unit Dose Blisters of 3 X 10s NDC 68180-193-13 80 mg/12.5 mg: supplied as capsule shaped, biconvex, bilayer, uncoated tablets; where hydrochlorothiazide layer is red coloured and telmisartan layer is white to off-white in colour but may have red specks; debossed with 'M32' on one side and 'LU' on other side. Bottle of 30's: NDC 68180-194-06 Bottle of 90's: NDC 68180-194-09 Unit Dose Blisters of 3 X 10s NDC 68180-194-13 80 mg/25 mg: supplied as capsule shaped, biconvex, bilayer, uncoated tablets; where hydrochlorothiazide layer is yellow coloured and telmisartan layer is white to off-white in colour but may have yellow specks; debossed with 'M33' on one side and 'LU' on other side. Bottle of 30's: NDC 68180-195-06 Bottle of 90's: NDC 68180-195-09 Unit Dose Blisters of 3 X 10s NDC 68180-195-13 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS Rx Only 40 mg/12.5 mg NDC 68180-193-06 A Bottle of 30 tablets IMAGE TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS Rx Only 80 mg/12.5 mg NDC 68180-194-06 A Bottle of 30 tablets Image TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS Rx Only 80 mg/25 mg NDC 68180-195-06 A Bottle of 30 tablets Image image-09 image-10 image-11

source: label

Packages (0)

No package records.

Ingredients (2)

hydrochlorothiazide (12.5 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": "92888a3c-daab-4cd1-b883-6ecbe682faa9", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130"], "spl_set_id": ["b88054b3-fafa-4b4e-acf5-5294e5555720"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Telmisartan and Hydrochlorothiazide", "product_id": "68180-194_92888a3c-daab-4cd1-b883-6ecbe682faa9", "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": "68180-194", "generic_name": "Telmisartan and Hydrochlorothiazide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA091351", "marketing_category": "ANDA", "marketing_start_date": "20140807", "listing_expiration_date": "20271231"}