Home Applications 077394 Application 077394
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM BICARBONATE SODIUM BICARBONATE INJECTABLE;INJECTION 0.9MEQ/ML No Yes 002 SODIUM BICARBONATE SODIUM BICARBONATE INJECTABLE;INJECTION 1MEQ/ML No 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 A077394-001 SODIUM BICARBONATE SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 A077394-002 SODIUM BICARBONATE SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09
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.
Product history page 1 of 3 · 86 observed 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 A077394-001 SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077394-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077394-001 SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077394-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077394-001 SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077394-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077394-001 SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077394-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION 2005-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION 2005-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077394-001 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION AP RS 2005-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077394-002 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP RS 2005-11-09 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 3 of 5 · 88 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join After Bite Kids SODIUM BICARBONATE Tender Corporation d/b/a Adventure Ready Brands 226c1420-d771-204f-e063-6294a90af9f6 2025-11-18 Warnings Name fallback generic name: SODIUM BICARBONATE After Bite X Tech SODIUM BICARBONATE Adventure Ready Brands e9e49ab4-3e1f-9fd4-e053-2a95a90a775a 2025-11-17 Warnings Name fallback generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE Henry Schein, Inc. da484a2f-154f-48b4-8467-7a86729204c3 2025-11-07 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Hospira, Inc. ea20a5eb-641e-48cd-bcfa-74c04c45dfda 2025-11-06 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Fresenius Kabi USA, LLC 0ab55004-bb63-436d-ad77-cd3796905370 2025-09-23 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Sodium Bicarbonate 10 GR (650 MG) SODIUM BICARBONATE Advanced Rx LLC 634e8d52-6d04-42f9-98f6-2634473b5dfd 2025-09-01 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE ProPharma Distribution 3d71b046-3e0b-054a-e063-6294a90a563a 2025-08-28 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Bryant Ranch Prepack ccf8e08c-2efb-4a92-a4c2-042dba2eacfa 2025-08-13 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Henry Schein, Inc. ea9ad1a6-84f2-44d8-bf93-fb8f3d3fce9c 2025-08-12 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Anti-Empacho SODIUM BICARBONATE Menper Distributors, Inc. 43807221-58f0-434d-be2d-fa0f54b95db8 2025-07-22 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate Antacid SODIUM BICARBONATE Menper Distributors Inc. 6efb4da0-03ae-4df6-acd7-e8023d20d4b3 2025-07-22 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Westminster Pharmaceuticals, LLC 9dcfc778-5fd6-4c68-8d37-a5385e374617 2025-07-08 Warnings Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE Anthea Pharma Private Limited 0df8cf62-4b49-4ec4-aae4-c4a3e6d76549 2025-06-26 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE AHHH Bite Relief SODIUM BICARBONATE 78271 25a1e070-9228-4ec9-e063-6294a90ad78d 2025-05-27 Warnings Name fallback generic name: SODIUM BICARBONATE Bestmade Natural Products Sodium Bicarbonate (Nat Bicarb) SODIUM BICARBONATE Bestmade Natural Products 2fad1d83-3c64-f1b3-e063-6294a90aa3e5 2025-05-26 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate 10 gr (650 mg) SODIUM BICARBONATE CitraGen Pharmaceuticals Inc. 650fa284-5829-588f-e053-2991aa0a9a0e 2025-01-30 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate 5 gr (325 mg) SODIUM BICARBONATE CitraGen Pharmaceuticals Inc. 68aadbd9-f1c6-8a23-e053-2991aa0afd96 2025-01-30 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE World Perfumes Inc a83544e4-ec09-1e95-e053-2995a90ab7b9 2025-01-15 Warnings Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Sodium Bicarbonate 10 gr SODIUM BICARBONATE Reliable 1 Laboratories LLC 321a772c-c44c-3d4e-e054-00144ff8d46c 2025-01-15 Warnings Name fallback generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE HF Acquisition Co LLC, DBA HealthFirst 9545d58c-1c49-79b3-e053-2995a90a9d40 2025-01-08 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52584-637 Sodium Bicarbonate Sodium Bicarbonate General Injectables & Vaccines, Inc ANDA Current 52584-637 Sodium Bicarbonate Sodium Bicarbonate General Injectables & Vaccines, Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39529 ORIG 2012-11-26 31234 ORIG 2005-11-18