METHOTREXATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Dostupné s:

Zydus Lifesciences Limited

INN (Mezinárodní Name):

METHOTREXATE

Složení:

METHOTREXATE 2.5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Methotrexate tablets, USP are indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.  Methotrexate tablets, USP are used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate  tablets, USP are used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate  tablets, USP are also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas. Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation . It is important to ensure that a psoriasis "flare" is not due to an undiagnos

Přehled produktů:

Oral Description Methotrexate tablets, USP are yellow, round, uncoated tablets, with debossing "L2" on one side and scoring on other side. They are supplied as follows: NDC 70771-1058-3 in bottle of 36 tablets NDC 70771-1058-9 in bottle of 90 tablets NDC 70771-1058-1 in bottle of 100 tablets   NDC 70771-1058-5 in bottle of 500 tablets NDC 70771-1058-0 in bottle of 1000 tablets NDC 70771-1058-7 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from light.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

METHOTREXATE - METHOTREXATE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
METHOTREXATE TABLET, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1058-1
Methotrexate tablets, USP 2.5 mg
Rx only
36 tablets
METHOTREXATE
methotrexate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1058
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)
METHOTREXATE
2.5 mg
Zydus Lifesciences Limited
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (YELLOW)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
L2
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1058-3
36 in 1 BOTTLE; Type 0: Not a Combination
Product
02/09/2017
2
NDC:70771-
1058-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
02/09/2017
3
NDC:70771-
1058-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
02/09/2017
4
NDC:70771-
1058-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
02/09/2017
5
NDC:70771-
1058-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
02/09/2017
6
NDC:70771-
1058-7
100 in 1 CARTON
02/09/2017
6
NDC:70771-
1058-2
1 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
ANDA207812
02/09/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Pharmaceuticals USA Inc. (156861945)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
863362789
ANALYSIS(70771-1058) , MANUFACTURE(70771-1058)
Revised: 10/2022