Acid Reducer

Product NDC
70000-0095
11-digit product format
700000095
Labeler code
70000
Product ID
70000-0095_2dd1726f-7e50-4cb4-86b6-1fb1424b0748
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
ANDA212088
Marketing category
ANDA
Marketing start
2021-04-30
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0095-1EA - Each70000-0095e2385539-73d3-44c4-98b8-8602695e2bf312021-11-09
70000-0095-2EA - Each70000-009578d3bc7c-1411-415e-af22-71fa911c25aa12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0095ACID REDUCER (ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [CARDINAL HEALTH (LEADER) 70000]7Legacy NDC20231027_24ee9374-aa31-44d4-85f8-47817ac023c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0095-1700000095011 BOTTLE in 1 CARTON (70000-0095-1) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent
70000-0095-2700000095023 BOTTLE, PLASTIC in 1 CARTON (70000-0095-2) > 1 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent