FDA.reportPublic FDA data

Application 220788

Type
ANDA
Sponsor
ASPIRO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM BICARBONATESODIUM BICARBONATESOLUTION;INTRAVENOUS5MEQ/10ML (0.5MEQ/ML)NoNo
002SODIUM BICARBONATESODIUM BICARBONATESOLUTION;INTRAVENOUS10MEQ/10ML (1MEQ/ML)NoNo
003SODIUM BICARBONATESODIUM BICARBONATESOLUTION;INTRAVENOUS50MEQ/50ML (1MEQ/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220788-001SODIUM BICARBONATESODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15
A220788-002SODIUM BICARBONATESODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15
A220788-003SODIUM BICARBONATESODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A220788-001AP
A220788-002AP
A220788-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A220788-001SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A220788-002SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A220788-003SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220788-001SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220788-002SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220788-003SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220788-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220788-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220788-003AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220788-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220788-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220788-003AP1a50c72e98297…

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 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
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
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
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 BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC4f97d398-2118-0874-e063-6394a90a4ad12026-04-16Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
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
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsName fallback
generic name: SODIUM BICARBONATE
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsName fallback
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHospira, Inc.084f5572-8c1f-4802-b179-ca0cc838fc682026-03-09Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.0c24b592-4bc8-456f-acac-9c9525844a062026-03-09Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE