NDC Code(s) : 35356-827-14, 35356-827-20, 35356-827-30, 35356-827-40
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Erythromycin Erythromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-827(NDC:24338-104)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythromycin(UNII: 63937KV33D)
(Erythromycin - UNII:63937KV33D) 		Erythromycin500 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone(UNII: 68401960MK)
D&C Red No. 30(UNII: 2S42T2808B)
aluminum oxide(UNII: LMI26O6933)
hydroxypropyl cellulose (type H)(UNII: RFW2ET671P)
hypromelloses(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
polyethylene glycols(UNII: 3WJQ0SDW1A)
propylene glycol(UNII: 6DC9Q167V3)
sodium citrate(UNII: 1Q73Q2JULR)
sodium hydroxide(UNII: 55X04QC32I)
sorbic acid(UNII: X045WJ989B)
sorbitan monooleate(UNII: 06XEA2VD56)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code EA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-827-1414 in 1 BOTTLE
2NDC:35356-827-2020 in 1 BOTTLE
3NDC:35356-827-3030 in 1 BOTTLE
4NDC:35356-827-4040 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061621 09/06/2011

PRINCIPAL DISPLAY PANEL

Image of Label