omeprazole

Generic: omeprazole

Labeler: geri-care pharmaceuticals, corp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler geri-care pharmaceuticals, corp
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
GERI-CARE PHARMACEUTICALS, CORP

Identifiers & Regulatory

Product NDC 57896-659
Product ID 57896-659_df05ccee-e8d0-43b2-a266-86afc1ce741c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207891
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

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 57896659
Hyphenated Format 57896-659

Supplemental Identifiers

RxCUI
402014
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 ANDA207891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (57896-659-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57896-659-14)
source: ndc

Packages (1)

57896-659-42 3 BOTTLE in 1 CARTON (57896-659-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57896-659-14)

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": "df05ccee-e8d0-43b2-a266-86afc1ce741c", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["8a77aea7-912e-43a3-bce3-f666b9b9c9bc"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["GERI-CARE PHARMACEUTICALS, CORP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (57896-659-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57896-659-14)", "package_ndc": "57896-659-42", "marketing_start_date": "20240523"}], "brand_name": "Omeprazole", "product_id": "57896-659_df05ccee-e8d0-43b2-a266-86afc1ce741c", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "57896-659", "generic_name": "Omeprazole", "labeler_name": "GERI-CARE PHARMACEUTICALS, CORP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207891", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}