Label: ERYTHROMYCIN tablet, film coated
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NDC Code(s):
70771-1548-1,
70771-1548-3,
70771-1548-5,
70771-1549-1, view more70771-1549-3, 70771-1549-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 21, 2023
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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ERYTHROMYCIN
erythromycin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1548 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) 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) 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) Score no score Shape OVAL (oval) Size 15mm Flavor Imprint Code llll Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1548-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 2 NDC:70771-1548-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 3 NDC:70771-1548-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212693 06/30/2023 ERYTHROMYCIN
erythromycin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1549 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) 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) 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) Score no score Shape OVAL (oval) Size 19mm Flavor Imprint Code 1048 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1549-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 2 NDC:70771-1549-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 3 NDC:70771-1549-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212693 06/30/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1548, 70771-1549) , MANUFACTURE(70771-1548, 70771-1549)
