omeprazole magnesium

Generic: omeprazole magnesium

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole magnesium
Generic Name omeprazole magnesium
Labeler dr. reddy's laboratories limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-397
Product ID 55111-397_fff9af9d-87b4-7d54-4cc4-c65b07556ec5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078878
Listing Expiration 2026-12-31
Marketing Start 2010-03-01

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111397
Hyphenated Format 55111-397

Supplemental Identifiers

RxCUI
198051
UNII
426QFE7XLK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omeprazole magnesium (source: ndc)
Generic Name omeprazole magnesium (source: ndc)
Application Number ANDA078878 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (55111-397-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 CARTON in 1 CARTON (55111-397-28) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 3 BOTTLE in 1 CARTON (55111-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (55111-397-39) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 CARTON in 1 CARTON (55111-397-42) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (55111-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (6)

55111-397-27 2 BOTTLE in 1 CARTON (55111-397-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 55111-397-28 2 CARTON in 1 CARTON (55111-397-28) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 55111-397-33 3 BOTTLE in 1 CARTON (55111-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 55111-397-39 3 BOTTLE in 1 CARTON (55111-397-39) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 55111-397-42 3 CARTON in 1 CARTON (55111-397-42) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 55111-397-52 1 BOTTLE in 1 CARTON (55111-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Omeprazole Magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fff9af9d-87b4-7d54-4cc4-c65b07556ec5", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["0e8fde83-a55c-edaf-3c66-e1fc77d0bc11"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (55111-397-27)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55111-397-27", "marketing_start_date": "20100301"}, {"sample": false, "description": "2 CARTON in 1 CARTON (55111-397-28)  / 2 BLISTER PACK in 1 CARTON (55111-397-74)  / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-397-28", "marketing_start_date": "20100301"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (55111-397-33)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55111-397-33", "marketing_start_date": "20100301"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (55111-397-39)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55111-397-39", "marketing_start_date": "20150901"}, {"sample": false, "description": "3 CARTON in 1 CARTON (55111-397-42)  / 2 BLISTER PACK in 1 CARTON (55111-397-74)  / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-397-42", "marketing_start_date": "20100301"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-397-52)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55111-397-52", "marketing_start_date": "20100301"}], "brand_name": "Omeprazole Magnesium", "product_id": "55111-397_fff9af9d-87b4-7d54-4cc4-c65b07556ec5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "55111-397", "generic_name": "Omeprazole Magnesium", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole Magnesium", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA078878", "marketing_category": "ANDA", "marketing_start_date": "20100301", "listing_expiration_date": "20261231"}