NDC Code(s) : 52125-514-20
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atenolol and ChlorthalidoneAtenolol and Chlorthalidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-514(NDC:0591-5782)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL(UNII: 50VV3VW0TI)
(ATENOLOL - UNII:50VV3VW0TI) 		ATENOLOL50 mg
CHLORTHALIDONE(UNII: Q0MQD1073Q)
(CHLORTHALIDONE - UNII:Q0MQD1073Q) 		CHLORTHALIDONE25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE K29/32(UNII: 390RMW2PEQ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score 2 pieces
Shape ROUND (TABLET) Size 8 mm
Flavor Imprint Code DAN;5782
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-514-20100 in 1 VIAL Type 0: Not a Combination Product22/02/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073665 02/22/2013 02/22/2014

PRINCIPAL DISPLAY PANEL

DRUG: Atenolol and Chlorthalidone


GENERIC: Atenolol and Chlorthalidone


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-514-20


ACTIVE INGREDIENT(S):

  • ATENOLOL 50mg in 1
  • CHLORTHALIDONE 25mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POVIDONE K29/32
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO


COLOR: white


SHAPE: ROUND


SCORE: Two even pieces


SIZE: 8 mm


IMPRINT: DAN;5782


PACKAGING: 100 in 1 VIAL



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