esomeprazole magnesium for delayed-release oral suspension

Generic: esomeprazole magnesium

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium for delayed-release oral suspension
Generic Name esomeprazole magnesium
Labeler torrent pharmaceuticals limited
Dosage Form GRANULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 5 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-547
Product ID 13668-547_48a063bb-b163-40f3-ad34-728d86410249
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212651
Listing Expiration 2026-12-31
Marketing Start 2025-03-05

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 13668547
Hyphenated Format 13668-547

Supplemental Identifiers

RxCUI
692576 692578 1297658 1297761
UNII
R6DXU4WAY9

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 esomeprazole magnesium for delayed-release oral suspension (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA212651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-547-94)
source: ndc

Packages (1)

13668-547-94 30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-547-94)

Ingredients (1)

esomeprazole magnesium (5 mg/1)

Linked Drug Pages (1)

Esomeprazole Magnesium for delayed-release oral suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48a063bb-b163-40f3-ad34-728d86410249", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["692576", "692578", "1297658", "1297761"], "spl_set_id": ["992b1830-55cc-4e95-8d6d-e7f796d5b373"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-547-94)", "package_ndc": "13668-547-94", "marketing_start_date": "20250305"}], "brand_name": "Esomeprazole Magnesium for delayed-release oral suspension", "product_id": "13668-547_48a063bb-b163-40f3-ad34-728d86410249", "dosage_form": "GRANULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "13668-547", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "brand_name_suffix": "for delayed-release oral suspension", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "5 mg/1"}], "application_number": "ANDA212651", "marketing_category": "ANDA", "marketing_start_date": "20250305", "listing_expiration_date": "20261231"}