signature care omeprazole

Generic: omeprazole

Labeler: safeway
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name signature care omeprazole
Generic Name omeprazole
Labeler safeway
Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Safeway

Identifiers & Regulatory

Product NDC 21130-128
Product ID 21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA209400
Listing Expiration 2026-12-31
Marketing Start 2018-07-11

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 21130128
Hyphenated Format 21130-128

Supplemental Identifiers

RxCUI
2003656
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 signature care omeprazole (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number NDA209400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 CARTON in 1 CARTON (21130-128-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 14 BLISTER PACK in 1 CARTON (21130-128-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

21130-128-55 3 CARTON in 1 CARTON (21130-128-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 21130-128-74 14 BLISTER PACK in 1 CARTON (21130-128-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

Signature Care Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eb0dd73c-7d2d-424f-a939-dcdb18ee21f1", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["2003656"], "spl_set_id": ["c76c4235-92d4-4384-8ddc-ceed0b928c48"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Safeway"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CARTON in 1 CARTON (21130-128-55)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "21130-128-55", "marketing_start_date": "20180711"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (21130-128-74)  / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "21130-128-74", "marketing_start_date": "20200702"}], "brand_name": "Signature Care Omeprazole", "product_id": "21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "21130-128", "generic_name": "omeprazole", "labeler_name": "Safeway", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Signature Care Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA209400", "marketing_category": "NDA", "marketing_start_date": "20180711", "listing_expiration_date": "20261231"}