ERYTHROMYCIN tablet, film coated

Erythromycin by

Drug Labeling and Warnings

Erythromycin by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1732-3 in bottle of 30 tablets

Erythromycin Tablets USP, 250 mg

Rx only

30 tablets

NDC: 70771-1733-3 in bottle of 30 tablets

Erythromycin Tablets USP, 500 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

ERYTHROMYCIN 
erythromycin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1732
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)	ERYTHROMYCIN	250 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color	PINK (peach to pink)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	1755
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1732-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023
2	NDC: 70771-1732-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023
3	NDC: 70771-1732-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215440	08/31/2023

ERYTHROMYCIN 
erythromycin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1733
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)	ERYTHROMYCIN	500 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color	PINK (light pink to pink)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	1756
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1733-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023
2	NDC: 70771-1733-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023
3	NDC: 70771-1733-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215440	08/31/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1732, 70771-1733) , MANUFACTURE(70771-1732, 70771-1733)