Home NDC 43598-010 Omeprazole and Sodium Bicarbonate
Product NDC 43598-010
11-digit product format 435980010
Labeler code 43598
Product ID 43598-010_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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217784-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL 2024-05-09 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Omeprazole and Sodium Bicarbonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE 20 mg/1 SODIUM BICARBONATE 1680 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KG60484QX9 Internal UNII lookup 8MDF5V39QO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 753562 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-010 OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC.,] 4 Current NDC 20240727_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-010-01 43598001001 1 PACKET in 1 CARTON (43598-010-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET 1 packet 2024-07-15 No No Current 43598-010-14 43598001014 14 PACKET in 1 CARTON (43598-010-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET 14 packet 2024-07-15 No No Current 43598-010-28 43598001028 28 PACKET in 1 CARTON (43598-010-28) / 1 POWDER, FOR SUSPENSION in 1 PACKET 28 packet 2024-07-15 No No Current 43598-010-42 43598001042 42 PACKET in 1 CARTON (43598-010-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET 42 packet 2024-07-15 No No Current