esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: chain drug marketing association inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler chain drug marketing association inc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC

Identifiers & Regulatory

Product NDC 63868-425
Product ID 63868-425_241fe5f8-399c-5ac9-fc77-f078e69ecb65
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207673
Listing Expiration 2026-12-31
Marketing Start 2018-07-06

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 63868425
Hyphenated Format 63868-425

Supplemental Identifiers

RxCUI
606726
UNII
R6DXU4WAY9

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 esomeprazole magnesium (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA207673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63868-425-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (63868-425-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (63868-425-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

63868-425-14 1 BOTTLE in 1 CARTON (63868-425-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 63868-425-28 2 BOTTLE in 1 CARTON (63868-425-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 63868-425-42 3 BOTTLE in 1 CARTON (63868-425-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Esomeprazole Magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "241fe5f8-399c-5ac9-fc77-f078e69ecb65", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["f95053ab-d6c5-ee92-58d1-6f203873f79c"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION INC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63868-425-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63868-425-14", "marketing_start_date": "20180706"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (63868-425-28)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63868-425-28", "marketing_start_date": "20190315"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (63868-425-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63868-425-42", "marketing_start_date": "20180706"}], "brand_name": "Esomeprazole Magnesium", "product_id": "63868-425_241fe5f8-399c-5ac9-fc77-f078e69ecb65", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "63868-425", "generic_name": "Esomeprazole Magnesium", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA207673", "marketing_category": "ANDA", "marketing_start_date": "20180706", "listing_expiration_date": "20261231"}