omeprazole delayed release

Generic: omeprazole 20mg

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

Drug Facts

Product Profile

Brand Name omeprazole delayed release
Generic Name omeprazole 20mg
Labeler time cap laboratories, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-731
Product ID 49483-731_442e2a90-4ac6-8adf-e063-6394a90a6fc2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218829
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

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 49483731
Hyphenated Format 49483-731

Supplemental Identifiers

RxCUI
402014
UPC
0349483731415
UNII
426QFE7XLK

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 omeprazole delayed release (source: ndc)
Generic Name omeprazole 20mg (source: ndc)
Application Number ANDA218829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (49483-731-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49483-731-45)
source: ndc

Packages (1)

49483-731-41 3 BOTTLE in 1 CARTON (49483-731-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49483-731-45)

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Omeprazole delayed release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "442e2a90-4ac6-8adf-e063-6394a90a6fc2", "openfda": {"upc": ["0349483731415"], "unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["40906798-cd84-fbd0-e063-6294a90a1d29"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (49483-731-41)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49483-731-45)", "package_ndc": "49483-731-41", "marketing_start_date": "20251215"}], "brand_name": "Omeprazole delayed release", "product_id": "49483-731_442e2a90-4ac6-8adf-e063-6394a90a6fc2", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "49483-731", "generic_name": "Omeprazole 20mg", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole delayed release", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA218829", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}