Basic Information
Telmisartan and Hydrochlorothiazide
68462-841
Regulatory Information
68462-841
ANDA202544
C73584
August 3, 2023
USA
These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral useInitial U.S. Approval: 2000
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
130597813
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
CROSPOVIDONE (120 .MU.M)
Code: 68401960MK
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MEGLUMINE
Code: 6HG8UB2MUY
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
SODIUM STEARYL FUMARATE
Code: 7CV7WJK4UI
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
SODIUM HYDROXIDE
Code: 55X04QC32I
Class Code: IACT
Active Moieties
TELMISARTAN
Code: U5SYW473RQ
HYDROCHLOROTHIAZIDE
Code: 0J48LPH2TH