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 20 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8406
Product ID 0615-8406_559600be-5b2c-4035-94b1-79ea261fa6a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212977
Listing Expiration 2026-12-31
Marketing Start 2019-02-20

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 06158406
Hyphenated Format 0615-8406

Supplemental Identifiers

RxCUI
198051
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 ANDA212977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-05)
  • 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-07)
  • 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-14)
  • 28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-28)
  • 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8406-30) / 5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-39)
source: ndc

Packages (6)

0615-8406-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-05) 0615-8406-07 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-07) 0615-8406-14 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-14) 0615-8406-28 28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-28) 0615-8406-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8406-30) / 5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 0615-8406-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-39)

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": "559600be-5b2c-4035-94b1-79ea261fa6a5", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["f226173f-4318-43e0-847a-8ea237e6b41d"], "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 (0615-8406-05)", "package_ndc": "0615-8406-05", "marketing_start_date": "20211004"}, {"sample": false, "description": "7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-07)", "package_ndc": "0615-8406-07", "marketing_start_date": "20230809"}, {"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-14)", "package_ndc": "0615-8406-14", "marketing_start_date": "20211004"}, {"sample": false, "description": "28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-28)", "package_ndc": "0615-8406-28", "marketing_start_date": "20240510"}, {"sample": false, "description": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8406-30)  / 5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0615-8406-30", "marketing_start_date": "20211004"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-39)", "package_ndc": "0615-8406-39", "marketing_start_date": "20211004"}], "brand_name": "Omeprazole", "product_id": "0615-8406_559600be-5b2c-4035-94b1-79ea261fa6a5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0615-8406", "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": "20 mg/1"}], "application_number": "ANDA212977", "marketing_category": "ANDA", "marketing_start_date": "20190220", "listing_expiration_date": "20261231"}