omeprazole

Generic: omeprazole

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler amerisource bergen
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20.6 mg/1

Manufacturer
AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-686
Product ID 46122-686_47dce86f-d184-44cf-8ee3-18dad7f401b8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210593
Listing Expiration 2026-12-31
Marketing Start 2021-03-31

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 46122686
Hyphenated Format 46122-686

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 (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA210593 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20.6 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 BLISTER PACK (46122-686-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74)
source: ndc

Packages (1)

46122-686-03 2 BOTTLE in 1 BLISTER PACK (46122-686-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74)

Ingredients (1)

omeprazole magnesium (20.6 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": "47dce86f-d184-44cf-8ee3-18dad7f401b8", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["47dce86f-d184-44cf-8ee3-18dad7f401b8"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 BLISTER PACK (46122-686-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74)", "package_ndc": "46122-686-03", "marketing_start_date": "20210331"}], "brand_name": "OMEPRAZOLE", "product_id": "46122-686_47dce86f-d184-44cf-8ee3-18dad7f401b8", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "46122-686", "generic_name": "OMEPRAZOLE", "labeler_name": "AMERISOURCE BERGEN", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OMEPRAZOLE", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20.6 mg/1"}], "application_number": "ANDA210593", "marketing_category": "ANDA", "marketing_start_date": "20210331", "listing_expiration_date": "20261231"}