berkley and jensen omeprazole (68391-103)

Drug Facts

Product Profile

Brand Name berkley and jensen omeprazole

Generic Name omeprazole

Labeler bjwc

Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Routes

ORAL

Active Ingredients

omeprazole 20 mg/1

Manufacturer

BJWC

Identifiers & Regulatory

Product NDC 68391-103

Product ID 68391-103_c7b50625-4920-4bb2-8eff-943670438248

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA209400

Listing Expiration 2026-12-31

Marketing Start 2020-03-09

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 68391103

Hyphenated Format 68391-103

Supplemental Identifiers

RxCUI

2003656

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 berkley and jensen omeprazole (source: ndc)

Generic Name omeprazole (source: ndc)

Application Number NDA209400 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

3 CARTON in 1 CARTON (68391-103-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

68391-103-55 3 CARTON in 1 CARTON (68391-103-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

berkley and jensen omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c7b50625-4920-4bb2-8eff-943670438248", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["2003656"], "spl_set_id": ["1729c60d-3475-45cd-b192-f88438403d1a"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CARTON in 1 CARTON (68391-103-55)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "68391-103-55", "marketing_start_date": "20200309"}], "brand_name": "berkley and jensen omeprazole", "product_id": "68391-103_c7b50625-4920-4bb2-8eff-943670438248", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68391-103", "generic_name": "omeprazole", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA209400", "marketing_category": "NDA", "marketing_start_date": "20200309", "listing_expiration_date": "20261231"}