omeprazole

Generic: omeprazole

Labeler: twin med llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler twin med llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Twin Med LLC

Identifiers & Regulatory

Product NDC 55681-306
Product ID 55681-306_c9a11bc6-0680-4030-871e-599417fccf57
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207891
Listing Expiration 2026-12-31
Marketing Start 2022-04-14

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 55681306
Hyphenated Format 55681-306

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
  • 1 BOTTLE in 1 CARTON (55681-306-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (55681-306-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

55681-306-14 1 BOTTLE in 1 CARTON (55681-306-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 55681-306-42 3 BOTTLE in 1 CARTON (55681-306-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

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": "c9a11bc6-0680-4030-871e-599417fccf57", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["346141b5-b49d-489a-84eb-18df8b940460"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Twin Med LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55681-306-14)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55681-306-14", "marketing_start_date": "20220414"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (55681-306-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "55681-306-42", "marketing_start_date": "20220414"}], "brand_name": "Omeprazole", "product_id": "55681-306_c9a11bc6-0680-4030-871e-599417fccf57", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "55681-306", "generic_name": "OMEPRAZOLE", "labeler_name": "Twin Med LLC", "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": "20220414", "listing_expiration_date": "20261231"}