Label: ESOMEPRAZOLE MAGNESIUM granule, delayed release
- NDC Code(s): 70771-1391-3, 70771-1392-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 19, 2023
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Esomeprazole Magnesium For Delayed-Release Oral Suspension
NDC 70771-1391-1
20 mg packet
Rx Only
Esomeprazole Magnesium For Delayed-Release Oral Suspension
NDC 70771-1391-3 unit dose packages of 30: 20 mg packets
Rx Only
Esomeprazole Magnesium For Delayed-Release Oral Suspension
NDC 70771-1392-1
40 mg packet
Rx Only
Esomeprazole Magnesium For Delayed-Release Oral Suspension
NDC 70771-1392-3 unit dose packages of 30: 40 mg packets
Rx Only
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INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium granule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1391 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSPOVIDONE (UNII: 2S7830E561) DEXTROSE (UNII: IY9XDZ35W2) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) STRAWBERRY (UNII: 4J2TY8Y81V) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BROWN (WHITE TO PALE BROWN) , RED (PALE RED TO RED) Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1391-3 30 in 1 CARTON; 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 ANDA206055 06/30/2023 ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium granule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1392 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 40 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSPOVIDONE (UNII: 2S7830E561) DEXTROSE (UNII: IY9XDZ35W2) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) STRAWBERRY (UNII: 4J2TY8Y81V) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BROWN (WHITE TO PALE BROWN) , RED (PALE RED TO RED) Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1392-3 30 in 1 CARTON; 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 ANDA206055 06/30/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1391, 70771-1392) , MANUFACTURE(70771-1391, 70771-1392)