NDC Code(s) : 43602-544-30, 43602-544-90, 43602-544-05
Packager : Ascent Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IBUPROFEN AND FAMOTIDINEIbuprofen and famotidine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-544
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM) 		IBUPROFEN800 mg
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE26.6 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
GLYCERIN(UNII: PDC6A3C0OX)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
TALC(UNII: 7SEV7J4R1U)
POVIDONE(UNII: FZ989GH94E)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code T396
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-544-3030 in 1 BOTTLE Type 0: Not a Combination Product10/06/2022
2NDC:43602-544-9090 in 1 BOTTLE Type 0: Not a Combination Product10/06/2022
3NDC:43602-544-05500 in 1 BOTTLE Type 0: Not a Combination Product10/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216814 10/06/2022

LABELER - Ascent Pharmaceuticals, Inc.(080938961)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis(43602-544), manufacture(43602-544), pack(43602-544)

PRINCIPAL DISPLAY PANEL

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