omeprazole

Generic: omeprazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-743
Product ID 43063-743_414b3f69-cc8c-44cb-e063-6394a90a8d5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075576
Listing Expiration 2026-12-31
Marketing Start 2009-01-21

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063743
Hyphenated Format 43063-743

Supplemental Identifiers

RxCUI
198051
UPC
0343063743904
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

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 ANDA075576 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-14)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-90)
source: ndc

Packages (4)

43063-743-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-14) 43063-743-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-30) 43063-743-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-60) 43063-743-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-90)

Ingredients (1)

omeprazole (20 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": "414b3f69-cc8c-44cb-e063-6394a90a8d5a", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0343063743904"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["e235ef89-3592-4ca1-8c13-d7ce84b1001c"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-14)", "package_ndc": "43063-743-14", "marketing_start_date": "20170324"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-30)", "package_ndc": "43063-743-30", "marketing_start_date": "20170208"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-60)", "package_ndc": "43063-743-60", "marketing_start_date": "20170324"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-90)", "package_ndc": "43063-743-90", "marketing_start_date": "20170324"}], "brand_name": "Omeprazole", "product_id": "43063-743_414b3f69-cc8c-44cb-e063-6394a90a8d5a", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "43063-743", "generic_name": "Omeprazole", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA075576", "marketing_category": "ANDA", "marketing_start_date": "20090121", "listing_expiration_date": "20261231"}