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
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-663
Product ID 71610-663_31e57817-b8c3-8178-e063-6294a90a0149
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212977
Listing Expiration 2026-12-31
Marketing Start 2020-12-10

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 71610663
Hyphenated Format 71610-663

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
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-00)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-30)
  • 4800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-51)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-53)
  • 9200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-56)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-60)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-70)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-80)
  • 2400 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-87)
  • 360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-94)
source: ndc

Packages (10)

71610-663-00 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-00) 71610-663-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-30) 71610-663-51 4800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-51) 71610-663-53 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-53) 71610-663-56 9200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-56) 71610-663-60 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-60) 71610-663-70 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-70) 71610-663-80 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-80) 71610-663-87 2400 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-87) 71610-663-94 360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-94)

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": "31e57817-b8c3-8178-e063-6294a90a0149", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["e87d2206-9c06-438c-947b-10b29a879d7b"], "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": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-00)", "package_ndc": "71610-663-00", "marketing_start_date": "20250401"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-30)", "package_ndc": "71610-663-30", "marketing_start_date": "20220908"}, {"sample": false, "description": "4800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-51)", "package_ndc": "71610-663-51", "marketing_start_date": "20240606"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-53)", "package_ndc": "71610-663-53", "marketing_start_date": "20220908"}, {"sample": false, "description": "9200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-56)", "package_ndc": "71610-663-56", "marketing_start_date": "20240606"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-60)", "package_ndc": "71610-663-60", "marketing_start_date": "20220908"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-70)", "package_ndc": "71610-663-70", "marketing_start_date": "20221115"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-80)", "package_ndc": "71610-663-80", "marketing_start_date": "20221121"}, {"sample": false, "description": "2400 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-87)", "package_ndc": "71610-663-87", "marketing_start_date": "20240606"}, {"sample": false, "description": "360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-94)", "package_ndc": "71610-663-94", "marketing_start_date": "20220919"}], "brand_name": "Omeprazole", "product_id": "71610-663_31e57817-b8c3-8178-e063-6294a90a0149", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71610-663", "generic_name": "Omeprazole", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20201210", "listing_expiration_date": "20261231"}