FDA.reportPublic FDA data

Application 019443

Type
NDA
Sponsor
ABBOTT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM BICARBONATE IN PLASTIC CONTAINERSODIUM BICARBONATEINJECTABLE;INJECTION0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002SODIUM BICARBONATE IN PLASTIC CONTAINERSODIUM BICARBONATEINJECTABLE;INJECTION1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019443-001SODIUM BICARBONATE IN PLASTIC CONTAINERSODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1986-06-03
N019443-002SODIUM BICARBONATE IN PLASTIC CONTAINERSODIUM BICARBONATE50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1986-06-03

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019443-001SODIUM BICARBONATE IN PLASTIC CONTAINER0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1986-06-03f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N019443-002SODIUM BICARBONATE IN PLASTIC CONTAINER1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1986-06-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019443-001SODIUM BICARBONATE IN PLASTIC CONTAINER0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1986-06-03e64feba35796…
2022-09-29 23:25 UTC2022-09N019443-002SODIUM BICARBONATE IN PLASTIC CONTAINER1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1986-06-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019443-001SODIUM BICARBONATE IN PLASTIC CONTAINER0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1986-06-03cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019443-002SODIUM BICARBONATE IN PLASTIC CONTAINER1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1986-06-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019443-001SODIUM BICARBONATE IN PLASTIC CONTAINER44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1986-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019443-002SODIUM BICARBONATE IN PLASTIC CONTAINER50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1986-06-03a50c72e98297…

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 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsName fallback
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsName fallback
generic name: SODIUM BICARBONATE
Humco Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc.aeaa34f6-216d-49f3-8393-c7bda96a3e322026-05-26WarningsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEVitamex USA, Corp5195cab5-bdda-2ddf-e063-6394a90ac9fe2026-05-11WarningsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsName fallback
generic name: SODIUM BICARBONATE
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsName fallback
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC4f97d398-2118-0874-e063-6394a90a4ad12026-04-16Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsName fallback
generic name: SODIUM BICARBONATE

Reported adverse events (FAERS/openFDA)#

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