NDC Code(s) : 61919-401-32, 61919-019-20
Packager : DIRECT RX

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMOXICILLINAMOXICILLIN POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-401(NDC:65862-071)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SODIUM BENZOATE(UNII: OJ245FE5EU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
XANTHAN GUM(UNII: TTV12P4NEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color pink Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61919-401-32100 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065334 01/01/2014
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-019(NDC:66685-1002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS500 mg
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID125 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
Product Characteristics
Color white Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code 500125;AMC
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61919-019-2020 in 1 BOTTLE Type 0: Not a Combination Product21/01/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065117 01/21/2021 12/31/2023

LABELER - DIRECT RX(079254320)

Establishment
Name Address ID/FEI Business Operations
DIRECT RX 079254320 relabel(61919-401, 61919-019)

PRINCIPAL DISPLAY PANEL

401

PRINCIPAL DISPLAY PANEL

01920