NDC Code(s) : 24236-049-60
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Doxycycline HyclateDoxycycline Hyclate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24236-049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE(UNII: 19XTS3T51U)
(DOXYCYCLINE ANHYDROUS - UNII:334895S862) 		DOXYCYCLINE ANHYDROUS100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
DIACETYLATED MONOGLYCERIDES(UNII: 5Z17386USF)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color blue (Blue/Blue Opaque) Score no score
Shape CAPSULE (CAPSULE) Size 11 mm
Flavor Imprint Code WW;3142
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24236-049-6060 in 1 VIAL Type 0: Not a Combination Product12/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062396 01/12/2012 01/12/2013

PRINCIPAL DISPLAY PANEL

DRUG: Doxycycline Hyclate

GENERIC: Doxycycline Hyclate

DOSAGE: CAPSULE, GELATIN COATED

ADMINSTRATION: ORAL

NDC: 24236-049-60

COLOR: blue

SHAPE: CAPSULE

SCORE: No score

SIZE: 21 mm

IMPRINT: West;ward;3142

PACKAGING: 60 in 1 VIAL

ACTIVE INGREDIENT(S):

  • DOXYCYCLINE HYCLATE 100mg in 1

INACTIVE INGREDIENT(S):

  • ALCOHOL
  • BUTYL ALCOHOL
  • FERROSOFERRIC OXIDE
  • PROPYLENE GLYCOL
  • D&C YELLOW NO. 10
  • FD&C RED NO. 40
  • FD&C BLUE NO. 2
  • TITANIUM DIOXIDE
  • FD&C BLUE NO. 1
  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • DIACETYLATED MONOGLYCERIDES
  • GELATIN
  • ACETIC ACID
  • SODIUM LAURYL SULFATE
  • LACTOSE MONOHYDRATE
  • SILICON DIOXIDE

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