FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
85509-1032
11-digit product format
855091032
Labeler code
85509
Product ID
85509-1032_3b2cf695-7671-4ad0-e063-6294a90aeb46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA204228
Marketing category
ANDA
Marketing start
2025-07-30
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40; 1100 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole and Sodium Bicarbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1
SODIUM BICARBONATE1100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9, 8MDF5V39QO
Rxcui616541

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1032-1Omeprazole and Sodium Bicarbonate15 in 1 BOTTLECAPSULE151
85509-1032-3Omeprazole and Sodium Bicarbonate30 in 1 BOTTLECAPSULE301
85509-1032-6Omeprazole and Sodium Bicarbonate60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1032-1EA - Each85509-10324c44b5b7-b0ac-484d-85f9-a17e3036fe0112025-09-12
85509-1032-3EA - Each85509-10325b2a135a-edb3-4cde-a451-100ae6c39f7312025-09-12
85509-1032-6EA - Each85509-103273130392-c1c3-4357-9318-162a7e2bbbf812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSN3b2cf6fd-72cb-fa53-e063-6394a90a674a1
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD3b2cf6fd-72cb-fa53-e063-6394a90a674a1
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSY3b2cf6fd-72cb-fa53-e063-6394a90a674a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-1032-18550910320115 CAPSULE in 1 BOTTLE (85509-1032-1) 15 capsule2025-07-30NoNoHistorical
85509-1032-38550910320330 CAPSULE in 1 BOTTLE (85509-1032-3) 30 capsule2025-07-30NoNoHistorical
85509-1032-68550910320660 CAPSULE in 1 BOTTLE (85509-1032-6) 60 capsule2025-07-30NoNoHistorical