omeprazole

Generic: omeprazole

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler northstar rx llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-634
Product ID 16714-634_3dba1b9f-de37-77e3-196d-0f4949648653
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078490
Listing Expiration 2026-12-31
Marketing Start 2022-06-03

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 16714634
Hyphenated Format 16714-634

Supplemental Identifiers

RxCUI
198051 200329
UPC
0316714123028
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 ANDA078490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-01)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-02)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-03)
source: ndc

Packages (3)

16714-634-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-01) 16714-634-02 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-02) 16714-634-03 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-03)

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": "3dba1b9f-de37-77e3-196d-0f4949648653", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0316714123028"], "unii": ["KG60484QX9"], "rxcui": ["198051", "200329"], "spl_set_id": ["40a75dc7-49b7-5c9d-6c5f-d4682ec6922e"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-01)", "package_ndc": "16714-634-01", "marketing_start_date": "20220603"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-02)", "package_ndc": "16714-634-02", "marketing_start_date": "20220603"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-03)", "package_ndc": "16714-634-03", "marketing_start_date": "20220603"}], "brand_name": "Omeprazole", "product_id": "16714-634_3dba1b9f-de37-77e3-196d-0f4949648653", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "16714-634", "generic_name": "Omeprazole", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA078490", "marketing_category": "ANDA", "marketing_start_date": "20220603", "listing_expiration_date": "20261231"}