omeprazole

Generic: omeprazole

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-161
Product ID 57237-161_aec12e35-60fb-416c-a2d0-a87cfdcb30a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203270
Listing Expiration 2026-12-31
Marketing Start 2015-08-19

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 57237161
Hyphenated Format 57237-161

Supplemental Identifiers

RxCUI
198051 199119 200329
UPC
0357237160305 0357237161302 0357237162309
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 ANDA203270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-01)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-30)
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-50)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-99)
source: ndc

Packages (5)

57237-161-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-01) 57237-161-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-30) 57237-161-50 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-50) 57237-161-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90) 57237-161-99 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-99)

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": "aec12e35-60fb-416c-a2d0-a87cfdcb30a6", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0357237160305", "0357237161302", "0357237162309"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119", "200329"], "spl_set_id": ["a1b1c61b-d4fe-433d-ad31-0b11758976fa"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-01)", "package_ndc": "57237-161-01", "marketing_start_date": "20150819"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-30)", "package_ndc": "57237-161-30", "marketing_start_date": "20150819"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-50)", "package_ndc": "57237-161-50", "marketing_start_date": "20150819"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90)", "package_ndc": "57237-161-90", "marketing_start_date": "20150819"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-99)", "package_ndc": "57237-161-99", "marketing_start_date": "20150819"}], "brand_name": "Omeprazole", "product_id": "57237-161_aec12e35-60fb-416c-a2d0-a87cfdcb30a6", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "57237-161", "generic_name": "Omeprazole", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA203270", "marketing_category": "ANDA", "marketing_start_date": "20150819", "listing_expiration_date": "20261231"}