NDC Code(s) : 24236-628-19
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OmeprazoleOmeprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24236-628(NDC:55111-158)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
SHELLAC(UNII: 46N107B71O)
POLOXAMER 407(UNII: TUF2IVW3M2)
POVIDONE(UNII: FZ989GH94E)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code Omepraole;20mg;R158
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24236-628-1990 in 1 BOTTLE Type 0: Not a Combination Product06/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 04/29/2015 12/12/2016

PRINCIPAL DISPLAY PANEL

DRUG: Omeprazole

GENERIC: Omeprazole

DOSAGE: CAPSULE, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 24236-628-19

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: Omepraole;20mg;R158

PACKAGING: 90 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • Omeprazole 20mg in 1

INACTIVE INGREDIENT(S):

  • D&C Red No. 28
  • ferric oxide yellow
  • FD&C Yellow No. 6
  • FD&C Red No. 40
  • gelatin
  • FD&C Blue No. 1
  • butyl alcohol
  • silicon dioxide
  • sodium lauryl sulfate
  • titanium dioxide
  • crospovidone
  • magnesium stearate
  • mannitol
  • meglumine
  • hypromelloses
  • methacrylic acid - ethyl acrylate copolymer (1:1) type A
  • poloxamer 407
  • povidone
  • propylene glycol
  • shellac
  • triethyl citrate

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