berkley and jensen heartburn treatment

Generic: esomeprazole

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley and jensen heartburn treatment
Generic Name esomeprazole
Labeler bjwc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole 20 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-898
Product ID 68391-898_ef5ff944-86d5-487c-86df-e255793a9f52
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207193
Listing Expiration 2027-12-31
Marketing Start 2017-09-25

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 68391898
Hyphenated Format 68391-898

Supplemental Identifiers

RxCUI
606726
UNII
N3PA6559FT
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 berkley and jensen heartburn treatment (source: ndc)
Generic Name esomeprazole (source: ndc)
Application Number ANDA207193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (68391-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68391-898-00)
source: ndc

Packages (1)

68391-898-03 3 BOTTLE in 1 CARTON (68391-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68391-898-00)

Ingredients (1)

esomeprazole (20 mg/1)

Linked Drug Pages (1)

berkley and jensen heartburn treatment ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef5ff944-86d5-487c-86df-e255793a9f52", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["N3PA6559FT"], "rxcui": ["606726"], "spl_set_id": ["2369c948-d46f-4ace-bc51-47477631bc43"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (68391-898-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68391-898-00)", "package_ndc": "68391-898-03", "marketing_start_date": "20170925"}], "brand_name": "berkley and jensen heartburn treatment", "product_id": "68391-898_ef5ff944-86d5-487c-86df-e255793a9f52", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68391-898", "generic_name": "Esomeprazole", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen heartburn treatment", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207193", "marketing_category": "ANDA", "marketing_start_date": "20170925", "listing_expiration_date": "20271231"}