members mark esomeprazole magnesium (68196-898)

Drug Facts

Product Profile

Brand Name members mark esomeprazole magnesium

Generic Name esomeprazole

Labeler sam's west inc

Dosage Form CAPSULE, DELAYED RELEASE

Routes

ORAL

Active Ingredients

esomeprazole 20 mg/1

Manufacturer

Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-898

Product ID 68196-898_566fb836-800f-4bbc-baf0-5ae366d06d55

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA207193

Listing Expiration 2027-12-31

Marketing Start 2019-12-06

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 68196898

Hyphenated Format 68196-898

Supplemental Identifiers

RxCUI

606726

UNII

N3PA6559FT

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 members mark esomeprazole magnesium (source: ndc)

Generic Name esomeprazole (source: ndc)

Application Number ANDA207193 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

3 BOTTLE in 1 CARTON (68196-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-898-01)

source: ndc

Packages (1)

68196-898-03 3 BOTTLE in 1 CARTON (68196-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-898-01)

Ingredients (1)

esomeprazole (20 mg/1)

Linked Drug Pages (1)

members mark esomeprazole magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "566fb836-800f-4bbc-baf0-5ae366d06d55", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["N3PA6559FT"], "rxcui": ["606726"], "spl_set_id": ["87913038-4b90-40a0-bce5-2d368bd5758c"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (68196-898-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-898-01)", "package_ndc": "68196-898-03", "marketing_start_date": "20191226"}], "brand_name": "members mark esomeprazole magnesium", "product_id": "68196-898_566fb836-800f-4bbc-baf0-5ae366d06d55", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68196-898", "generic_name": "esomeprazole", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "members mark esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207193", "marketing_category": "ANDA", "marketing_start_date": "20191206", "listing_expiration_date": "20271231"}