METFORMIN HYDROCHLORIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Dostępny od:

Zydus Lifesciences Limited

INN (International Nazwa):

METFORMIN HYDROCHLORIDE

Skład:

METFORMIN HYDROCHLORIDE 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

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