omeprazole

Generic: omeprazole

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8079
Product ID 0615-8079_0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091672
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

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 06158079
Hyphenated Format 0615-8079

Supplemental Identifiers

RxCUI
200329
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 ANDA091672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05)
  • 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-07)
  • 28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-28)
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39)
source: ndc

Packages (4)

0615-8079-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05) 0615-8079-07 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-07) 0615-8079-28 28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-28) 0615-8079-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39)

Ingredients (1)

omeprazole (40 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": "0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["d1e0c8fc-1f15-45a4-a80f-653a1dae5e56"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05)", "package_ndc": "0615-8079-05", "marketing_start_date": "20141031"}, {"sample": false, "description": "7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-07)", "package_ndc": "0615-8079-07", "marketing_start_date": "20181102"}, {"sample": false, "description": "28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-28)", "package_ndc": "0615-8079-28", "marketing_start_date": "20250110"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39)", "package_ndc": "0615-8079-39", "marketing_start_date": "20141031"}], "brand_name": "Omeprazole", "product_id": "0615-8079_0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0615-8079", "generic_name": "Omeprazole", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA091672", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}