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FDA Drug information

Telmisartan and Hydrochlorothiazide

Read time: 1 mins
Marketing start date: 21 Jul 2024

Summary of product characteristics


Effective Time

20221017

Version

5

Spl Product Data Elements

Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TELMISARTAN TELMISARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SILICON DIOXIDE CROSPOVIDONE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL MEGLUMINE POVIDONE SODIUM HYDROXIDE SODIUM STEARYL FUMARATE SORBITOL TALC Mottled Light brown to Mottled Brown WHITE TO OFF WHITE Oblong Shaped 513 Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TELMISARTAN TELMISARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SILICON DIOXIDE CROSPOVIDONE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL MEGLUMINE POVIDONE SODIUM HYDROXIDE SODIUM STEARYL FUMARATE SORBITOL TALC Mottled Light brown to Mottled Brown WHITE TO OFF WHITE Oblong Shaped 514 Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TELMISARTAN TELMISARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SILICON DIOXIDE CROSPOVIDONE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL MEGLUMINE POVIDONE SODIUM HYDROXIDE SODIUM STEARYL FUMARATE SORBITOL TALC FERRIC OXIDE YELLOW Mottled Light brown to Mottled Brown YELLOW Oblong Shaped 515

Application Number

ANDA204221

Brand Name

Telmisartan and Hydrochlorothiazide

Generic Name

Telmisartan and Hydrochlorothiazide

Product Ndc

70771-1124

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1123-9 in bottle of 90 tablets Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg R x only 90 tablets NDC 70771-1124-9 in bottle of 90 tablets Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg R x only 90 tablets NDC 70771-1125-9 in bottle of 90 tablets Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg R x only 90 tablets Telmisartan HCTZ Tablet Telmisartan HCTZ Tablet Telmisartan HCTZ Tablet

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