NDC Code(s) : 52125-140-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BiaxinClarithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-140(NDC:0074-3368)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
VANILLIN(UNII: CHI530446X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POVIDONES(UNII: FZ989GH94E)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: HHT01ZNK31)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code a;KT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-140-0230 in 1 BLISTER PACK Type 0: Not a Combination Product16/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050662 07/16/2012 07/16/2013

PRINCIPAL DISPLAY PANEL

DRUG: Biaxin

GENERIC: Clarithromycin

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 52125-140-02

COLOR: yellow

SHAPE: OVAL

SCORE: No score

SIZE: 15 mm

IMPRINT: a;KT

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CLARITHROMYCIN 250mg in 1

INACTIVE INGREDIENT(S):

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
  • TITANIUM DIOXIDE
  • TALC
  • VANILLIN
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • HYPROMELLOSES
  • POVIDONES
  • STEARIC ACID
  • CROSCARMELLOSE SODIUM
  • FD&C BLUE NO. 1
  • D&C YELLOW NO. 10
  • MAGNESIUM STEARATE
  • PROPYLENE GLYCOL
  • SORBIC ACID
  • SILICON DIOXIDE
  • SORBITAN MONOOLEATE

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