omeprazole

Generic: omeprazole

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler golden state medical supply, inc.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-814
Product ID 51407-814_47d4a3d4-ff3b-0ca6-e063-6394a90acd69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203481
Listing Expiration 2027-12-31
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 51407814
Hyphenated Format 51407-814

Supplemental Identifiers

RxCUI
200329
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 ANDA203481 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-01)
  • 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-05)
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-30)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-90)
source: ndc

Packages (4)

51407-814-01 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-01) 51407-814-05 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-05) 51407-814-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-30) 51407-814-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-90)

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": "47d4a3d4-ff3b-0ca6-e063-6394a90acd69", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["f27b3518-d5c1-1229-e053-2a95a90ab56f"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Golden State Medical Supply, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-01)", "package_ndc": "51407-814-01", "marketing_start_date": "20240319"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-05)", "package_ndc": "51407-814-05", "marketing_start_date": "20240319"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-30)", "package_ndc": "51407-814-30", "marketing_start_date": "20240319"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-90)", "package_ndc": "51407-814-90", "marketing_start_date": "20240319"}], "brand_name": "OMEPRAZOLE", "product_id": "51407-814_47d4a3d4-ff3b-0ca6-e063-6394a90acd69", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "51407-814", "generic_name": "OMEPRAZOLE", "labeler_name": "Golden State Medical Supply, Inc.", "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": "20271231"}