omeprazole

Generic: omeprazole

Labeler: h e b
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler h e b
Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-354
Product ID 37808-354_51d6a6ce-e096-4152-876e-472f6b47e5bb
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA209400
Listing Expiration 2026-12-31
Marketing Start 2018-03-05

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 37808354
Hyphenated Format 37808-354

Supplemental Identifiers

RxCUI
2003656
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 NDA209400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 42 BLISTER PACK in 1 CARTON (37808-354-55) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 14 BLISTER PACK in 1 CARTON (37808-354-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

37808-354-55 42 BLISTER PACK in 1 CARTON (37808-354-55) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 37808-354-74 14 BLISTER PACK in 1 CARTON (37808-354-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

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": "51d6a6ce-e096-4152-876e-472f6b47e5bb", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["2003656"], "spl_set_id": ["344b5548-e5c0-45bf-bc3f-73af50bd5913"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "42 BLISTER PACK in 1 CARTON (37808-354-55)  / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "37808-354-55", "marketing_start_date": "20180305"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (37808-354-74)  / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "37808-354-74", "marketing_start_date": "20180305"}], "brand_name": "omeprazole", "product_id": "37808-354_51d6a6ce-e096-4152-876e-472f6b47e5bb", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "37808-354", "generic_name": "omeprazole", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA209400", "marketing_category": "NDA", "marketing_start_date": "20180305", "listing_expiration_date": "20261231"}