esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler time cap laboratories, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-718
Product ID 49483-718_08ad180e-e87a-ba6f-e063-6394a90a2bc7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217264
Listing Expiration 2026-12-31
Marketing Start 2023-11-14

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 49483718
Hyphenated Format 49483-718

Supplemental Identifiers

RxCUI
606726
UPC
0349483718416
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 (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA217264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (49483-718-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

49483-718-41 3 BOTTLE in 1 CARTON (49483-718-41) / 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": "08ad180e-e87a-ba6f-e063-6394a90a2bc7", "openfda": {"upc": ["0349483718416"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["08acf79f-f50d-8416-e063-6294a90a2704"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (49483-718-41)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "49483-718-41", "marketing_start_date": "20231114"}], "brand_name": "Esomeprazole magnesium", "product_id": "49483-718_08ad180e-e87a-ba6f-e063-6394a90a2bc7", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "49483-718", "generic_name": "esomeprazole magnesium", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA217264", "marketing_category": "ANDA", "marketing_start_date": "20231114", "listing_expiration_date": "20261231"}