Omeprazole/Sodium Bicarbonate

Product NDC
49884-268
11-digit product format
498840268
Labeler code
49884
Product ID
49884-268_d01c3df2-2286-4a20-bbdb-939148dd30dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA079182
Marketing category
ANDA
Marketing start
2016-07-18
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 mg/1; mg/1
Pharmacologic classes
Alkalinizing Activity [MoA], 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-268-112022-09-27C16284748780-1e4f33bdf-ade9-d8a0-e053-dadaa90a6e4e297a32ab-c602-4322-b861-7a335684e852
49884-268-112022-07-29C16284748780-1e4f33bdf-ade9-d8a0-e053-dadaa90a6e4e297a32ab-c602-4322-b861-7a335684e852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-268-114988402681130 PACKET in 1 CARTON (49884-268-11) > 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-268-52) 30 packet2016-07-180000-00-00NoNoCurrent