Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)
Zydus Lifesciences Limited
AZATHIOPRINE
AZATHIOPRINE 25
ORAL
PRESCRIPTION DRUG
Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine tablets on these variables has not been tested in controlled trials. Azathioprine tablets, USP are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine tablets. The combined use of azathioprine tablets with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for
Azathioprine Tablets USP, 25 mg are yellow, round, flat, radial edge tablets with bisect on one side and other side is plain; one side of the bisect is debossed with logo of "ZD" and other side is debossed with "11" and are supplied as follows: NDC 70771-1139-1 in bottles of 100 tablets NDC 70771-1139-5 in bottles of 500 tablets Azathioprine Tablets USP, 75 mg are yellow, round, flat, radial-edged tablets with bisect on one side and other side of tablet is plain; one side of the bisect is debossed with "ZD" and other side is debossed with "10" and are supplied as follows: NDC 70771-1140-1 in bottles of 100 tablets NDC 70771-1140-5 in bottles of 500 tablets Azathioprine Tablets USP, 100 mg are yellow, round, flat, radial-edged tablets with bisect on one side and other side of tablet is plain; one side of the bisect is debossed with "ZD" and other side is debossed with "09" and are supplied as follows: NDC 70771-1141-1 in bottles of 100 tablets NDC 70771-1141-5 in bottles of 500 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature] in a dry place and protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Abbreviated New Drug Application
AZATHIOPRINE - AZATHIOPRINE TABLET ZYDUS LIFESCIENCES LIMITED ---------- AZATHIOPRINE TABLETS, USP PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1140-1 in bottle of 100 tablets Azathioprine Tablets USP, 75 mg 100 tablets Rx only 75 MG LABEL NDC 70771-1141-1 in bottle of 100 tablets Azathioprine Tablets USP, 100 mg 100 tablets Rx only 100 MG LABEL NDC 70771-1139-1 in bottle of 100 tablets Azathioprine Tablets USP, 25 mg 100 tablets Rx only 25 MG LABEL AZATHIOPRINE azathioprine tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1139 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZ ATHIOPRINE 25 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PRODUCT CHARACTERISTICS COLOR YELLOW (YELLOW) SCORE 2 pieces SHAPE ROUND (ROUND) SIZE 6mm FLAVOR IMPRINT CODE Z D;11 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1139-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:70771- 1139-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA077621 12/02/2017 AZATHIOPRINE azathioprine tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1140 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZ ATHIOPRINE 75 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3 Les hele dokumentet