omeprazole

Generic: omeprazole

Labeler: strategic sourcing services llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler strategic sourcing services llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
STRATEGIC SOURCING SERVICES LLC

Identifiers & Regulatory

Product NDC 70677-1098
Product ID 70677-1098_252eeb77-6319-49df-9259-fcf2f917b2b5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207891
Listing Expiration 2026-12-31
Marketing Start 2023-08-11

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 706771098
Hyphenated Format 70677-1098

Supplemental Identifiers

RxCUI
402014
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 ANDA207891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (70677-1098-1) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

70677-1098-1 1 BLISTER PACK in 1 CARTON (70677-1098-1) / 14 TABLET, 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": "252eeb77-6319-49df-9259-fcf2f917b2b5", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["56380ccc-6fc2-4e1b-bd87-da24c9aa31cd"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["STRATEGIC SOURCING SERVICES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70677-1098-1)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "70677-1098-1", "marketing_start_date": "20230811"}], "brand_name": "Omeprazole", "product_id": "70677-1098_252eeb77-6319-49df-9259-fcf2f917b2b5", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70677-1098", "generic_name": "Omeprazole", "labeler_name": "STRATEGIC SOURCING SERVICES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207891", "marketing_category": "ANDA", "marketing_start_date": "20230811", "listing_expiration_date": "20261231"}