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 2 of 5 · 88 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sodium Bicarbonate SODIUM BICARBONATE Hospira, Inc. 8664c7ce-707b-4c6c-9ce4-7160b5f877f8 2026-04-06 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Rapidol Sodium Bicarbonate SODIUM BICARBONATE Pharmadel LLC b4c9a653-6f51-7c98-e053-2995a90ada37 2026-03-26 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate Antacid SODIUM BICARBONATE Aphena Pharma Solutions - Tennessee, LLC bba7d5bf-c94b-4ee4-a399-9a2818d84c78 2026-03-23 Warnings Name fallback generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE Hospira, Inc. 084f5572-8c1f-4802-b179-ca0cc838fc68 2026-03-09 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Hospira, Inc. 0c24b592-4bc8-456f-acac-9c9525844a06 2026-03-09 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE Sodium Bicarbonate 5 gr SODIUM BICARBONATE TWIN MED LLC 12cad432-99db-4a9b-8619-82794e29409e 2026-03-01 Warnings Name fallback generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE Amneal Pharmaceuticals Private Limited ba92f45a-0187-4709-aa70-462b8dae09e9 2026-02-09 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 oz SODIUM BICARBONATE Evi Labs 4979a339-4ad4-9cdd-e063-6394a90a0acc 2026-01-28 Warnings Name fallback generic name: SODIUM BICARBONATE D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PURO SODIUM BICARBONATE Evi Labs 485f9eb1-6535-c47c-e063-6394a90ae32c 2026-01-14 Warnings Name fallback generic name: SODIUM BICARBONATE Sanar Baking Soda 8oz 100% pure SODIUM BICARBONATE Evi Labs 47e7f801-3176-288c-e063-6394a90abef4 2026-01-08 Warnings Name fallback generic name: SODIUM BICARBONATE DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 Floz SODIUM BICARBONATE Evi Labs 47330d09-7db1-254d-e063-6294a90ae7de 2026-01-07 Warnings Name fallback generic name: SODIUM BICARBONATE DE LA CRUZ SODIUM BICARBONATE ANTACID SODIUM BICARBONATE DLC Laboratories, Inc. fc469943-9749-45ee-93f7-90fdbcdc7215 2026-01-07 Warnings Name fallback generic name: SODIUM BICARBONATE De La Cruz Desempacho SODIUM BICARBONATE DLC LABORATORIES, INC. 741e105a-3ed2-4fc7-ab06-273e515a2d16 2026-01-07 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate 10 gr SODIUM BICARBONATE GRAXCELL PHARMACEUTICAL, LLC 897dbb09-fb47-4e03-8cae-bf76d48a7a03 2025-12-25 Warnings Name fallback generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE ProPharma Distribution 3867f743-c2cf-a646-e063-6394a90a82e1 2025-12-18 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE After Bite Advanced SODIUM BICARBONATE Tender Corporation d/b/a Adventure Ready Brands 223d1de8-7940-bbdc-e063-6294a90a51d8 2025-12-18 Warnings Name fallback generic name: SODIUM BICARBONATE BM Sodium bicarbonate (Nat Bicarb) SODIUM BICARBONATE BM Private Limited 38044eae-7237-6add-e063-6294a90a827b 2025-12-02 Warnings Name fallback generic name: SODIUM BICARBONATE Sodium Bicarbonate SODIUM BICARBONATE Civica a10fdfbc-94a0-49ab-b26c-de1df042bc89 2025-11-24 Warnings, Adverse reactions Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE SODIUM BICARBONATE SODIUM BICARBONATE Glenmark Pharmaceuticals Inc., USA f38d0dfc-9bcc-4224-a202-885c9ad0beae 2025-11-20 Warnings, Adverse reactions Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE Itch Eraser Sensitive SODIUM BICARBONATE Tender Corporation d/b/a Adventure Ready Brands 2250525a-45c2-42ea-e063-6394a90ac001 2025-11-18 Warnings Name fallback 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