Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Zydus Lifesciences Limited
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 50 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated a
Doxycycline Tablets USP, 50 mg contains doxycycline monohydrate equivalent to 50 mg of doxycycline. Doxycycline Tablets USP, 50 mg are off-white to pale yellow colored, round, biconvex, beveled edged film coated tablets debossed with "1121" on one side and plain on other side and are supplied as follows: NDC 70771-1006-1 in bottle of 100 tablets Doxycycline Tablets USP, 75 mg contains doxycycline monohydrate equivalent to 75 mg of doxycycline. Doxycycline Tablets USP, 75 mg are light orange to creamish orange colored, round, biconvex, beveled edged film coated tablets debossed with "1122" on one side and plain on other side and are supplied as follows: NDC 70771-1007-1 in bottle of 100 tablets Doxycycline Tablets USP, 100 mg contains doxycycline monohydrate equivalent to 100 mg of doxycycline. Doxycycline Tablets USP, 100 mg are lemon yellow to buff colored, round, biconvex, beveled edged film coated tablets debossed with "1123" on one side and plain on other side and are supplied as follows: NDC 70771-1008-7 in bottle of 50 tablets NDC 70771-1008-8 in bottle of 250 tablets Doxycycline Tablets USP, 150 mg contains doxycycline monohydrate equivalent to 150 mg of doxycycline. Doxycycline Tablets USP, 150 mg are dark orange to creamish orange colored, round, biconvex, beveled edged film coated tablets debossed with scoreline on one side and debossed "1124" on other side and are supplied as follows: NDC 70771-1009-3 in bottle of 30 tablets NDC 70771-1009-1 in bottle of 100 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DISPENSE IN A TIGHT LIGHT RESISTANT CONTAINER AS DEFINED IN THE USP/NF.
Abbreviated New Drug Application
DOXYCYCLINE - DOXYCYCLINE TABLET, FILM COATED ZYDUS LIFESCIENCES LIMITED ---------- DOXYCYCLINE TABLETS, USP PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1006-1 DOXYCYCLINE TABLETS, USP – 50 MG Rx only 100 Tablets NDC 70771-1007-1 DOXYCYCLINE TABLETS, USP – 75 MG Rx only 100 Tablets NDC 70771-1008-7 DOXYCYCLINE TABLETS, USP – 100 MG Rx only 50 Tablets NDC 70771-1009-1 DOXYCYCLINE TABLETS, USP – 150 MG Rx only 100 Tablets DOXYCYCLINE doxycycline tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1006 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 50 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PRODUCT CHARACTERISTICS COLOR YELLOW (PALE YELLOW) SCORE no score SHAPE ROUND (biconvex, beveled edged) SIZE 7mm FLAVOR IMPRINT CODE 1121 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1006-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA209582 01/11/2018 DOXYCYCLINE doxycycline tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1007 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 75 mg INACTIVE Прочитайте повний документ