omeprazole

Generic: omeprazole

Labeler: camber consumer care inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler camber consumer care inc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Camber Consumer Care Inc

Identifiers & Regulatory

Product NDC 69230-318
Product ID 69230-318_ee873df8-2b35-9bc7-e053-2a95a90a0f83
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211732
Listing Expiration 2026-12-31
Marketing Start 2020-03-25

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 69230318
Hyphenated Format 69230-318

Supplemental Identifiers

RxCUI
402014
UPC
0369230318355
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

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 ANDA211732 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10)
  • 1 BLISTER PACK in 1 CARTON (69230-318-32) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (69230-318-33) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (69230-318-34) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (69230-318-35) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (69230-318-36) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (69230-318-37) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (8)

69230-318-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05) 69230-318-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10) 69230-318-32 1 BLISTER PACK in 1 CARTON (69230-318-32) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 69230-318-33 2 BLISTER PACK in 1 CARTON (69230-318-33) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 69230-318-34 3 BLISTER PACK in 1 CARTON (69230-318-34) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 69230-318-35 1 BOTTLE in 1 CARTON (69230-318-35) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 69230-318-36 2 BOTTLE in 1 CARTON (69230-318-36) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 69230-318-37 3 BOTTLE in 1 CARTON (69230-318-37) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

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": "ee873df8-2b35-9bc7-e053-2a95a90a0f83", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0369230318355"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["9c856d3a-e38f-4006-a43a-ec1a9fa0f057"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Camber Consumer Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05)", "package_ndc": "69230-318-05", "marketing_start_date": "20201029"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10)", "package_ndc": "69230-318-10", "marketing_start_date": "20201029"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69230-318-32)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "69230-318-32", "marketing_start_date": "20200325"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69230-318-33)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "69230-318-33", "marketing_start_date": "20200325"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (69230-318-34)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "69230-318-34", "marketing_start_date": "20200325"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69230-318-35)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69230-318-35", "marketing_start_date": "20200325"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (69230-318-36)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69230-318-36", "marketing_start_date": "20200325"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (69230-318-37)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69230-318-37", "marketing_start_date": "20200325"}], "brand_name": "Omeprazole", "product_id": "69230-318_ee873df8-2b35-9bc7-e053-2a95a90a0f83", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69230-318", "generic_name": "Omeprazole", "labeler_name": "Camber Consumer Care Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA211732", "marketing_category": "ANDA", "marketing_start_date": "20200325", "listing_expiration_date": "20261231"}