Home NDC 70954-797-20 Omeprazole and Sodium Bicarbonate
Product NDC 70954-797
Requested package NDC 70954-797-20
11-digit product format 709540797
Labeler code 70954
Product ID 70954-797_63c3bd6c-a586-4ec0-8f45-ed936936dfeb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Omeprazole and Sodium Bicarbonate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA219161
Marketing category ANDA
Marketing start 2026-01-15
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219161-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 A219161-002 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A219161-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219161-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219161-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219161-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219161-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219161-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219161-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219161-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219161-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219161-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB 2025-12-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 753557 Internal RxNorm lookup 753562 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-797-10 Omeprazole and Sodium Bicarbonate 1 in 1 PACKET POWDER, FOR SUSPENSION 1 1 70954-797-20 Omeprazole and Sodium Bicarbonate 30 in 1 CARTON POWDER, FOR SUSPENSION 30 1
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 · 1 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 70954-797-20 70954079720 30 PACKET in 1 CARTON (70954-797-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-797-10) 30 packet 2026-01-15 No No Current