Esomeprazole Magnesium

Product NDC
55700-889
11-digit product format
557000889
Labeler code
55700
Product ID
55700-889_23e16930-99bf-4f36-b7bf-2ca62912c7ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA205606
Marketing category
ANDA
Marketing start
2020-11-09
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-889-302025-01-16C16284748780-1f386c649-cb75-0266-e053-dadaa90a7c1a78b88baa-925a-40da-ac69-0fb94d168d78
55700-889-302023-01-30C16284748780-1f386c649-cb75-0266-e053-dadaa90a7c1a78b88baa-925a-40da-ac69-0fb94d168d78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-889-09557000889091 BLISTER PACK in 1 CARTON (55700-889-09) > 9 TABLET in 1 BLISTER PACK1 blister pack2021-02-040000-00-00NoNoCurrent
55700-889-305570008893030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-889-30) 2020-11-090000-00-00NoNoCurrent