Esomeprazole

Generic: Esomeprazole

Labeler: Sun Pharmaceutical Industries, Inc.
NDC Directory HUMAN OTC DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Esomeprazole
Generic Name Esomeprazole
Labeler Sun Pharmaceutical Industries, Inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

ESOMEPRAZOLE MAGNESIUM 20 mg/1

Identifiers & Regulatory

Product NDC 63304-740
Product ID 63304-740_6ac3f3a4-98df-4eb3-9b9e-c85253811b85
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212866
Listing Expiration 2026-12-31
Marketing Start 2019-11-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304740
Hyphenated Format 63304-740

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 (source: ndc)
Generic Name Esomeprazole (source: ndc)
Application Number ANDA212866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63304-740-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (63304-740-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (63304-740-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

63304-740-14 1 BOTTLE in 1 CARTON (63304-740-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 63304-740-27 2 BOTTLE in 1 CARTON (63304-740-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 63304-740-44 3 BOTTLE in 1 CARTON (63304-740-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

ESOMEPRAZOLE MAGNESIUM (20 mg/1)

Linked Drug Pages (1)

Esomeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6ac3f3a4-98df-4eb3-9b9e-c85253811b85", "openfda": {"upc": ["0363304740141"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["86aa9813-351c-4fbe-80f6-4f861f25fe1d"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63304-740-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63304-740-14", "marketing_start_date": "20191130"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (63304-740-27)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63304-740-27", "marketing_start_date": "20191130"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (63304-740-44)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63304-740-44", "marketing_start_date": "20191130"}], "brand_name": "Esomeprazole", "product_id": "63304-740_6ac3f3a4-98df-4eb3-9b9e-c85253811b85", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "63304-740", "generic_name": "Esomeprazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA212866", "marketing_category": "ANDA", "marketing_start_date": "20191130", "listing_expiration_date": "20261231"}