NDC Code(s) : 58914-170-14, 58914-170-60
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarafateSucralfate SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58914-170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUCRALFATE(UNII: XX73205DH5)
(SUCRALFATE - UNII:XX73205DH5) 		SUCRALFATE1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)0.004 mg in 10 mL
GLYCERIN(UNII: PDC6A3C0OX)87.92 mg in 10 mL
METHYLCELLULOSE, UNSPECIFIED(UNII: Z944H5SN0H)
METHYLPARABEN(UNII: A2I8C7HI9T)1.78 mg in 10 mL
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
WATER(UNII: 059QF0KO0R)618.006 mg in 10 mL
SORBITOL SOLUTION(UNII: 8KW3E207O2)177.62 mg in 10 mL
Product Characteristics
Color pink Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58914-170-14420 mL in 1 BOTTLE Type 0: Not a Combination Product16/12/1993
2NDC:58914-170-606 in 1 BOX 16/12/1993
210 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product16/12/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019183 12/16/1993

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

NDC 58914-170-14
Carafate ®
(sucralfate)
Oral
Suspension
1g/ 10mL

One 420 mL Bottle

Rx ONLY

PRINCIPAL DISPLAY PANEL NDC 58914-170-14 Carafate® (sucralfate) Oral Suspension 1g/ 10mL One 420 mL Bottle Rx ONLY