omeprazole

Generic: omeprazole

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

Drug Facts

Product Profile

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

omeprazole 40 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-645
Product ID 55111-645_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078490
Listing Expiration 2027-12-31
Marketing Start 2014-03-01

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111645
Hyphenated Format 55111-645

Supplemental Identifiers

RxCUI
198051 199119 200329
UPC
0355111643012 0355111644019
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

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 (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA078490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-01)
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-05)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-10)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-30)
  • 12 BOTTLE in 1 CARTON (55111-645-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (55111-645-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-645-79)
source: ndc

Packages (6)

55111-645-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-01) 55111-645-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-05) 55111-645-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-10) 55111-645-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-30) 55111-645-34 12 BOTTLE in 1 CARTON (55111-645-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE 55111-645-78 10 BLISTER PACK in 1 CARTON (55111-645-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-645-79)

Ingredients (1)

omeprazole (40 mg/1)

Linked Drug Pages (1)

Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0355111643012", "0355111644019"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119", "200329"], "spl_set_id": ["603d2d06-c5e8-4378-a422-8dca1a410af7"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-01)", "package_ndc": "55111-645-01", "marketing_start_date": "20140301"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-05)", "package_ndc": "55111-645-05", "marketing_start_date": "20140301"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-10)", "package_ndc": "55111-645-10", "marketing_start_date": "20251001"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-30)", "package_ndc": "55111-645-30", "marketing_start_date": "20140301"}, {"sample": false, "description": "12 BOTTLE in 1 CARTON (55111-645-34)  / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55111-645-34", "marketing_start_date": "20150514"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-645-78)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-645-79)", "package_ndc": "55111-645-78", "marketing_start_date": "20140301"}], "brand_name": "Omeprazole", "product_id": "55111-645_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "55111-645", "generic_name": "Omeprazole", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA078490", "marketing_category": "ANDA", "marketing_start_date": "20140301", "listing_expiration_date": "20271231"}