omeprazole

Generic: omeprazole

Labeler: dr. reddys laboratories inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler dr. reddys laboratories inc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-286
Product ID 43598-286_ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207740
Listing Expiration 2026-12-31
Marketing Start 2018-11-06

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 43598286
Hyphenated Format 43598-286

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 ANDA207740 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (43598-286-25) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 2 BOTTLE in 1 CARTON (43598-286-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52)
  • 2 BLISTER PACK in 1 CARTON (43598-286-32) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43598-286-70)
  • 3 BOTTLE in 1 CARTON (43598-286-33) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52)
  • 3 BLISTER PACK in 1 CARTON (43598-286-37) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52)
  • 1 BLISTER PACK in 1 CARTON (43598-286-74) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (7)

43598-286-25 2 BLISTER PACK in 1 CARTON (43598-286-25) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 43598-286-27 2 BOTTLE in 1 CARTON (43598-286-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) 43598-286-32 2 BLISTER PACK in 1 CARTON (43598-286-32) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43598-286-70) 43598-286-33 3 BOTTLE in 1 CARTON (43598-286-33) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) 43598-286-37 3 BLISTER PACK in 1 CARTON (43598-286-37) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 43598-286-52 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) 43598-286-74 1 BLISTER PACK in 1 CARTON (43598-286-74) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

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": "ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["4b3b389d-a151-d851-cb05-64eb49979e5e"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (43598-286-25)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-286-25", "marketing_start_date": "20181106"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (43598-286-27)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52)", "package_ndc": "43598-286-27", "marketing_start_date": "20181106"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (43598-286-32)  / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43598-286-70)", "package_ndc": "43598-286-32", "marketing_start_date": "20181106"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (43598-286-33)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52)", "package_ndc": "43598-286-33", "marketing_start_date": "20181106"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (43598-286-37)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-286-37", "marketing_start_date": "20181106"}, {"sample": false, "description": "14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52)", "package_ndc": "43598-286-52", "marketing_start_date": "20181106"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (43598-286-74)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-286-74", "marketing_start_date": "20181106"}], "brand_name": "Omeprazole", "product_id": "43598-286_ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "43598-286", "generic_name": "Omeprazole", "labeler_name": "Dr. Reddys Laboratories Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207740", "marketing_category": "ANDA", "marketing_start_date": "20181106", "listing_expiration_date": "20261231"}