omeprazole

Generic: omeprazole

Labeler: pld acquisitions llc dba avma pharma solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler pld acquisitions llc dba avma pharma solutions
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20.6 mg/1

Manufacturer
PLD Acquisitions LLC DBA Avma Pharma Solutions

Identifiers & Regulatory

Product NDC 63548-4080
Product ID 63548-4080_8289695b-99ab-44e6-a237-da93ec951d1e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206582
Listing Expiration 2026-12-31
Marketing Start 2024-10-31

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 635484080
Hyphenated Format 63548-4080

Supplemental Identifiers

RxCUI
402014
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 (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA206582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20.6 mg/1
source: ndc
Packaging
  • 42 BLISTER PACK in 1 CARTON (63548-4080-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 14 BLISTER PACK in 1 CARTON (63548-4080-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 28 BLISTER PACK in 1 CARTON (63548-4080-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

63548-4080-2 42 BLISTER PACK in 1 CARTON (63548-4080-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 63548-4080-4 14 BLISTER PACK in 1 CARTON (63548-4080-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 63548-4080-8 28 BLISTER PACK in 1 CARTON (63548-4080-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole magnesium (20.6 mg/1)

Linked Drug Pages (1)

Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8289695b-99ab-44e6-a237-da93ec951d1e", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["6a1aeb95-5760-4363-816a-fa8305979c50"], "manufacturer_name": ["PLD Acquisitions LLC DBA Avma Pharma Solutions"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "42 BLISTER PACK in 1 CARTON (63548-4080-2)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "63548-4080-2", "marketing_start_date": "20241031"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (63548-4080-4)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "63548-4080-4", "marketing_start_date": "20241031"}, {"sample": false, "description": "28 BLISTER PACK in 1 CARTON (63548-4080-8)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "63548-4080-8", "marketing_start_date": "20241031"}], "brand_name": "Omeprazole", "product_id": "63548-4080_8289695b-99ab-44e6-a237-da93ec951d1e", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "63548-4080", "generic_name": "Omeprazole", "labeler_name": "PLD Acquisitions LLC DBA Avma Pharma Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20.6 mg/1"}], "application_number": "ANDA206582", "marketing_category": "ANDA", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}