Carvedilol
Summary of product characteristics
Effective Time
20221031
Version
7
Spl Product Data Elements
Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND Z;1 Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND ZC40 Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 TALC TITANIUM DIOXIDE SILICON DIOXIDE WHITE TO OFF-WHITE ROUND ZC41 Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 TALC TITANIUM DIOXIDE SILICON DIOXIDE WHITE TO OFF-WHITE ROUND ZC42
Application Number
ANDA077614
Brand Name
Carvedilol
Generic Name
Carvedilol
Product Ndc
65841-616
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-616-01 in bottle of 100 Tablets Carvedilol Tablets USP, 3.125 mg R x only 100 Tablets NDC 65841-617-01 in bottle of 100 Tablets Carvedilol Tablets USP, 6.25 mg R x only 100 Tablets NDC 65841-618-01 in bottle of 100 Tablets Carvedilol Tablets USP, 12.5 mg R x only 100 Tablets NDC 65841-619-01 in bottle of 100 Tablets Carvedilol Tablets USP, 25 mg R x only 100 Tablets Carvedilol Tablets, 3.125 mg Carvedilol Tablets, 6.25 mg Carvedilol Tablets, 12.5 mg Carvedilol Tablets,25 mg
380 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.
Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.