FDA.reportPublic FDA data

Omeprazole, Sodium bicarbonate

Product NDC
69784-701
11-digit product format
697840701
Labeler code
69784
Product ID
69784-701_fc55b9b7-0dc1-4304-abe0-aa4495e55ada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole, Sodium bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Woodward Pharma Services LLC
Application
ANDA212587
Marketing category
ANDA
Marketing start
2021-05-11
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 mg/1; 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69784-701-302025-09-17C16284748780-1f386c649-f32b-0266-e053-dadaa90a7c1a5cb3b887-919f-4c47-aa07-eb10182dfcc3
69784-701-302023-01-30C16284748780-1f386c649-f32b-0266-e053-dadaa90a7c1a5cb3b887-919f-4c47-aa07-eb10182dfcc3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-701-30EA - Each69784-701b284432d-0a8f-43fc-9814-861d6d40cfce12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-701OMEPRAZOLE, SODIUM BICARBONATE CAPSULE [WOODWARD PHARMA SERVICES LLC]3Legacy NDC20210609_5cb3b887-919f-4c47-aa07-eb10182dfcc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN2cc8c7b4-cc93-4855-bd19-2a1167123cd0103
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD2cc8c7b4-cc93-4855-bd19-2a1167123cd0103
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY2cc8c7b4-cc93-4855-bd19-2a1167123cd0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69784-701-306978407013030 CAPSULE in 1 BOTTLE (69784-701-30) 30 capsule2021-05-110000-00-00NoNoCurrent
69784-701-776978407017730 CAPSULE in 1 BOTTLE (69784-701-77) 30 capsule2021-05-110000-00-00NoNoCurrent