Erythromycin Tablets, USP

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]

ERYTHROMYCIN- erythromycin tablet, film coated 
Zydus Lifesciences Limited

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Erythromycin Tablets, USP

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

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	03/25/2025
2	NDC: 70771-1732-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023	03/25/2025
3	NDC: 70771-1732-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215440	08/31/2023	04/17/2025

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	03/25/2025
2	NDC: 70771-1733-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023	03/25/2025
3	NDC: 70771-1733-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2023	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215440	08/31/2023	04/17/2025

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)

Revised: 4/2025

Document Id: 5a5743cd-66ec-4550-a740-52e964b97dee

34391-3

Set id: 866cf00e-f606-44fc-87a3-1798a63a48fe

Version: 3

Effective Time: 20250417