DOXYCYCLINE tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Fáanlegur frá:

Zydus Lifesciences Limited

INN (Alþjóðlegt nafn):

DOXYCYCLINE

Samsetning:

DOXYCYCLINE ANHYDROUS 50 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

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