FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
55700-693
11-digit product format
557000693
Labeler code
55700
Product ID
55700-693_f1a8eeda-4bcd-42c9-9da8-ee21c5977860
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA203481
Marketing category
ANDA
Marketing start
2018-10-26
Marketing end
0000-00-00
Substance
OMEPRAZOLE
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-693-14EA - Each55700-693c71332b1-d6d3-48d6-8cf2-ce558acded1e12018-12-13
55700-693-30EA - Each55700-693f81938f0-a7a9-4f19-8ebc-0c11e2c2c7bb12018-12-13
55700-693-60EA - Each55700-69350baf100-8060-4cd6-a470-48e9235ba9ba12018-12-13
55700-693-90EA - Each55700-693dbddf506-2381-47da-9f25-77c467d60b5e12018-12-13