topcare omeprazole

Generic: omeprazole

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare omeprazole
Generic Name omeprazole
Labeler topco associates llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-915
Product ID 36800-915_e1557259-5889-4677-981e-ebd3970162c8
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022032
Listing Expiration 2026-12-31
Marketing Start 2008-02-29

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 36800915
Hyphenated Format 36800-915

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 topcare omeprazole (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number NDA022032 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (36800-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 2 CARTON in 1 CARTON (36800-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 3 CARTON in 1 CARTON (36800-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 14 BLISTER PACK in 1 CARTON (36800-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (5)

36800-915-01 1 BOTTLE in 1 CARTON (36800-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 36800-915-03 3 BOTTLE in 1 CARTON (36800-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 36800-915-30 2 CARTON in 1 CARTON (36800-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 36800-915-55 3 CARTON in 1 CARTON (36800-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 36800-915-74 14 BLISTER PACK in 1 CARTON (36800-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

TopCare Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e1557259-5889-4677-981e-ebd3970162c8", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["4d98665d-38db-4c08-8406-cc0e45f7ab7c"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-915-01)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "36800-915-01", "marketing_start_date": "20101011"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (36800-915-03)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "36800-915-03", "marketing_start_date": "20111228"}, {"sample": false, "description": "2 CARTON in 1 CARTON (36800-915-30)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-915-30", "marketing_start_date": "20080229"}, {"sample": false, "description": "3 CARTON in 1 CARTON (36800-915-55)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-915-55", "marketing_start_date": "20080229"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (36800-915-74)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-915-74", "marketing_start_date": "20080229"}], "brand_name": "TopCare Omeprazole", "product_id": "36800-915_e1557259-5889-4677-981e-ebd3970162c8", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "36800-915", "generic_name": "Omeprazole", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA022032", "marketing_category": "NDA", "marketing_start_date": "20080229", "listing_expiration_date": "20261231"}