DOXYCYCLINE HYCLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Available from:

Zydus Lifesciences Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate 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 the empiric selection of therapy. Doxycycline hyclate tablets are indicated for  the treatment of 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

Product summary:

Each film-coated tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Doxycycline Hyclate Tablets USP, equivalent to 100 mg doxycycline: Light yellow to beige colored, round, beveled edge, biconvex tablets debossed with "D77" on one side and plain on other side.   NDC 70771-1104-7 in bottle of 50 tablets NDC 70771-1104-1 in bottle of 100 tablets NDC 70771-1104-5 in bottle of 500 tablets               NDC 70771-1104-0 in bottle of 1000 tablets NDC 70771-1104-4 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE - DOXYCYCLINE HYCLATE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
DOXYCYCLINE HYCLATE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1104-7
Doxycycline Hyclate Tablets, 100 mg
Rx only
50 tablets
DOXYCYCLINE HYCLATE
doxycycline hyclate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1104
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS -
UNII:334895S862)
DOXYCYCLINE
ANHYDROUS
100 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (BEIGE COLORED)
SCORE
no score
SHAPE
ROUND (BICONVEX)
SIZE
9mm
FLAVOR
IMPRINT CODE
D77
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1104-7
50 in 1 BOTTLE; Type 0: Not a Combination
Product
04/02/2018
2
NDC:70771-
1104-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
04/02/2018
3
NDC:70771-
1104-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
04/02/2018
4
NDC:70771-
1104-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
04/02/2018
5
NDC:70771-
1104-4
10 in 1 CARTON
04/02/2018
5
NDC:70771-
1104-2
10 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
ANDA207773
04/02/2018
LABELER -
Zydus Lifesciences Limited (918596198)
Zydus Lifesciences Limited
REGISTRANT -
Zydus Lifesciences Limited (863362789)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zyd