ALBENDAZOLE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN)

متاح من:

Zydus Lifesciences Limited

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . Albendazole tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . Albendazole tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole tablets. Risk Summary Based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In

ملخص المنتج:

Albendazole Tablets USP, 200 mg are white to off-white, round, film coated tablets debossed '1021' on one side and plain on the other side and are supplied as: NDC 70771-1103-7 in bottle of 28 tablets with child-resistant closure NDC 70771-1103-1 in bottle of 100 tablets NDC 70771-1103-5 in bottle of 500 tablets NDC 70771-1103-8 in bottle of 2 tablets (1 x 2 unit-dose blister pack) with child-resistant closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ALBENDAZOLE - ALBENDAZOLE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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ALBENDAZOLE TABLETS, FOR ORAL USE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1103-7
Albendazole Tablets USP, 200 mg
28 Tablets
Rx only
ALBENDAZOLE
albendazole tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1103
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN)
ALBENDAZ OLE
200 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
12mm
FLAVOR
IMPRINT CODE
1021
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1103-7
28 in 1 BOTTLE; Type 0: Not a Combination
Product
12/17/2018
2
NDC:70771-
1103-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
12/17/2018
3
NDC:70771-
1103-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
12/17/2018
4
NDC:70771-
1103-8
1 in 1 BOTTLE
12/17/2018
4
2 in 1 BLISTER PACK; Type 0: Not a Combination
Product
5
NDC:70771-
1103-6
2 in 1 BOTTLE; Type 0: Not a Combination
Product
05/11/2020
6
NDC:70771-
1103-3
1 in 1 CARTON
05/27/2020
6
2 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA208979
12/17/2018
LABELER -
Zydus Lifesciences Limited (918596198)
Zydus Lif