Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Zydus Lifesciences Limited
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [see Warnings and Precautions (5.1) ]. - Hypersensitivity to metformin. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary Limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations]. No adverse developmental effects were observed wh
Metformin Hydrochloride Tablets, USP Metformin Hydrochloride Tablets USP, 500 mg are white to off-white, round shaped, film-coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows. NDC 65841-028-16 / NDC 65841-809-16 in bottles of 90 tablets NDC 65841-028-01 / NDC 65841-809-01 in bottles of 100 tablets NDC 65841-028-05 / NDC 65841-809-05 in bottles of 500 tablets NDC 65841-028-10 / NDC 65841-809-10 in bottles of 1000 tablets NDC 65841-028-77 / NDC 65841-809-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Metformin Hydrochloride Tablets USP, 850 mg are white to off-white, oval shaped, film-coated tablets debossed with the logo of "69" on one side and "Z" on the other side and are supplied as follows. NDC 65841-029-16 / NDC 65841-810-16 in bottles of 90 tablets NDC 65841-029-01 / NDC 65841-810-01 in bottles of 100 tablets NDC 65841-029-05 / NDC 65841-810-05 in bottles of 500 tablets NDC 65841-029-10 / NDC 65841-810-10 in bottles of 1000 tablets NDC 65841-029-77 / NDC 65841-810-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Metformin Hydrochloride Tablets USP, 1000 mg are white to off-white, oval shaped, biconvex, film-coated tablets with bisect on both the sides; one side of the bisect is debossed with "Z" and other side of the bisect is debossed with "71" and are supplied as follows. NDC 65841-030-16 / NDC 65841-811-16 in bottles of 90 tablets NDC 65841-030-01 / NDC 65841-811-01 in bottles of 100 tablets NDC 65841-030-05 / NDC 65841-811-05 in bottles of 500 tablets NDC 65841-030-10 / NDC 65841-811-10 in bottles of 1000 tablets NDC 65841-030-77 / NDC 65841-811-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED ZYDUS LIFESCIENCES LIMITED ---------- METFORMIN HYDROCHLORIDE TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-028-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 mg Rx only 100 tablets NDC 65841-809-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 mg Rx only 100 tablets NDC 65841-029-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 850 mg Rx only 100 tablets NDC 65841-810-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 850 mg Rx only 100 tablets NDC 65841-030-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets NDC 65841-811-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-028 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE TO OFF-WHITE) SCORE no score SHAPE ROUND (ROUND) SIZE 13mm FLAVOR IMPRINT CODE 70;Z CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841-028- 16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 2 NDC:65841-028- 01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 3 NDC:65841-028- 05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 4 NDC:65841-028- 10 1000 in 1 BOTTLE; Type 0: Not a Combination Pro Lees het volledige document