Omeprazole and Sodium Bicarbonate

Product NDC
13107-117
11-digit product format
131070117
Labeler code
13107
Product ID
13107-117_1f2db15b-a212-4eff-9cad-c971a5a89da4
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA204923
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-117OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC]2Legacy NDC20190912_bfaf1e69-cbe9-4dde-8f65-6e730f47120a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-117-14131070117141 BOTTLE in 1 CARTON (13107-117-14) > 14 CAPSULE in 1 BOTTLE1 bottle2014-09-300000-00-00NoNoCurrent
13107-117-28131070117282 BOTTLE in 1 CARTON (13107-117-28) > 14 CAPSULE in 1 BOTTLE2 bottle2014-09-300000-00-00NoNoCurrent
13107-117-42131070117423 BOTTLE in 1 CARTON (13107-117-42) > 14 CAPSULE in 1 BOTTLE3 bottle2014-09-300000-00-00NoNoCurrent