FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
43598-307
Requested package NDC
43598-307-42
11-digit product format
435980307
Labeler code
43598
Product ID
43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.,
Application
ANDA217784
Marketing category
ANDA
Marketing start
2024-07-15
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 1680 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217784-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-0984e616aacf4f…
2026-08-18 06:07:402026-07A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-091e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217784-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORAL2024-05-09a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1
SODIUM BICARBONATE1680 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
753562Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6b5f808-4a49-1303-9711-badb022ecd70Available on FDA.report

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-307OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC.,]4Current NDC20240727_c6b5f808-4a49-1303-9711-badb022ecd70.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid Reducer PowderOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,6f8452f8-8c2c-6700-a11d-1531023056c52025-03-03WarningsExact identifier
application applno (ANDA): 217784
application number: ANDA217784
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
application applno (ANDA): 217784
application number: ANDA217784
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsExact identifier
application applno (ANDA): 217784
application number: ANDA217784
ndc (package): 43598-307-42
ndc (product): 43598-307
ndc11 (package): 43598030742

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNc6b5f808-4a49-1303-9711-badb022ecd704
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDc6b5f808-4a49-1303-9711-badb022ecd704
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYc6b5f808-4a49-1303-9711-badb022ecd704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-307-424359803074242 PACKET in 1 CARTON (43598-307-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET42 packet2024-07-15NoNoCurrent