Doxycycline Hyclate: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 100 mg

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DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-276(NDC:53489-120)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color orange (light orange) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code MP;37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-276-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:72789-276-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:72789-276-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:72789-276-71 210 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:72789-276-74 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
6 NDC:72789-276-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
7 NDC:72789-276-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062677 07/10/1986
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-276)

Revised: 01/2023 PD-Rx Pharmaceuticals, Inc.

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