omeprazole

Generic: omeprazole

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-688
Product ID 71610-688_1ac7526d-c24f-66d3-e063-6294a90a42d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203481
Listing Expiration 2026-12-31
Marketing Start 2017-07-03

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 71610688
Hyphenated Format 71610-688

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 ANDA203481 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-30)
  • 1300 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-43)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-53)
  • 650 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-58)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-60)
  • 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-80)
  • 2400 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-87)
source: ndc

Packages (7)

71610-688-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-30) 71610-688-43 1300 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-43) 71610-688-53 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-53) 71610-688-58 650 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-58) 71610-688-60 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-60) 71610-688-80 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-80) 71610-688-87 2400 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-87)

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": "1ac7526d-c24f-66d3-e063-6294a90a42d1", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["3e99b78b-7fb8-4514-a3db-58e59cd429d8"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-30)", "package_ndc": "71610-688-30", "marketing_start_date": "20230120"}, {"sample": false, "description": "1300 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-43)", "package_ndc": "71610-688-43", "marketing_start_date": "20240610"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-53)", "package_ndc": "71610-688-53", "marketing_start_date": "20230120"}, {"sample": false, "description": "650 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-58)", "package_ndc": "71610-688-58", "marketing_start_date": "20240610"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-60)", "package_ndc": "71610-688-60", "marketing_start_date": "20230120"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-80)", "package_ndc": "71610-688-80", "marketing_start_date": "20230120"}, {"sample": false, "description": "2400 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-87)", "package_ndc": "71610-688-87", "marketing_start_date": "20240610"}], "brand_name": "OMEPRAZOLE", "product_id": "71610-688_1ac7526d-c24f-66d3-e063-6294a90a42d1", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71610-688", "generic_name": "OMEPRAZOLE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OMEPRAZOLE", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA203481", "marketing_category": "ANDA", "marketing_start_date": "20170703", "listing_expiration_date": "20261231"}