NDC Code(s) : 70518-1545-0, 70518-1545-2, 70518-1545-1
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarbamazepineCarbamazepine TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1545(NDC:51672-4125)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE(UNII: 33CM23913M)
(CARBAMAZEPINE - UNII:33CM23913M) 		CARBAMAZEPINE400 mg
Inactive Ingredients
Ingredient Name Strength
DIETHYL PHTHALATE(UNII: UF064M00AF)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score no score
Shape OVAL (capsule shaped) Size 17 mm
Flavor Imprint Code T29
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-1545-030 in 1 BLISTER PACK Type 0: Not a Combination Product17/10/2018
2NDC:70518-1545-1100 in 1 BOX 11/05/2022
2NDC:70518-1545-21 in 1 POUCH Type 0: Not a Combination Product17/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078115 10/17/2018

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: Carbamazepine

GENERIC: Carbamazepine

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-1545-0

NDC: 70518-1545-1

NDC: 70518-1545-2

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 17 mm

IMPRINT: T29

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • Carbamazepine 400mg in 1

INACTIVE INGREDIENT(S):

  • starch, corn
  • diethyl phthalate
  • lactose monohydrate
  • magnesium stearate
  • MICROCRYSTALLINE CELLULOSE
  • sodium starch glycolate type a potato

MM2

MM2