omeprazole

Generic: omeprazole

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8771
Product ID 68788-8771_c3183e18-e844-49e6-8546-270232604cbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078490
Listing Expiration 2027-12-31
Marketing Start 2024-11-20

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 687888771
Hyphenated Format 68788-8771

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 ANDA078490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-1)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-6)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-8)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-9)
source: ndc

Packages (5)

68788-8771-1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-1) 68788-8771-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-3) 68788-8771-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-6) 68788-8771-8 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-8) 68788-8771-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-9)

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": "c3183e18-e844-49e6-8546-270232604cbf", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["288bdd5e-a0ac-4c5c-abe0-93183a28dcdd"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-1)", "package_ndc": "68788-8771-1", "marketing_start_date": "20241120"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-3)", "package_ndc": "68788-8771-3", "marketing_start_date": "20241120"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-6)", "package_ndc": "68788-8771-6", "marketing_start_date": "20241120"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-8)", "package_ndc": "68788-8771-8", "marketing_start_date": "20241120"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-9)", "package_ndc": "68788-8771-9", "marketing_start_date": "20241120"}], "brand_name": "Omeprazole", "product_id": "68788-8771_c3183e18-e844-49e6-8546-270232604cbf", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68788-8771", "generic_name": "Omeprazole", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA078490", "marketing_category": "ANDA", "marketing_start_date": "20241120", "listing_expiration_date": "20271231"}