NDC Code(s) : 49349-212-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Loxapine SuccinateLoxapine Succinate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-212
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOXAPINE SUCCINATE(UNII: X59SG0MRYU)
(LOXAPINE - UNII:LER583670J) 		LOXAPINE50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
EDETATE CALCIUM DISODIUM(UNII: 25IH6R4SGF)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM PROPIONATE(UNII: DK6Y9P42IN)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code WATSON;372
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-212-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/10/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072062 10/19/2009 03/06/2017

PRINCIPAL DISPLAY PANEL

DRUG: Loxapine

GENERIC: Loxapine

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 49349-212-02

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: Watson;372;50;mg

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LOXAPINE SUCCINATE 50mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • PROPYLPARABEN
  • SODIUM LAURYL SULFATE
  • POLACRILIN POTASSIUM
  • SODIUM PROPIONATE
  • TALC
  • TITANIUM DIOXIDE
  • BENZYL ALCOHOL
  • BUTYLPARABEN
  • EDETATE CALCIUM DISODIUM
  • FD&C BLUE NO. 1
  • GELATIN
  • MAGNESIUM STEARATE
  • METHYLPARABEN

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