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 43.

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
2026-09-14 22:38:342026-08A220788-001SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A220788-002SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A220788-003SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-1584e616aacf4f…
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
2026-09-14 22:38:342026-08A220788-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A220788-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A220788-003AP184e616aacf4f…
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 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCb620938d-ab2d-0934-e053-2a95a90a84832023-05-23Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCd1636b56-ad83-4439-e053-2a95a90a135e2023-05-02Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEInternational Medication Systems, Limited77698221-a01d-4568-a7bc-d3d4e982875d2021-12-15Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLCbfc9c321-665c-ca97-e053-2995a90a79542021-04-12Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
Sodium Bicarbonate AntacidSODIUM BICARBONATERichmond Pharmaceuticals, Inc.e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce2017-11-01WarningsName fallback
generic name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATERichmond Pharmaceuticals, Inc.fa10d93d-b3ed-4675-a117-f573d9e72bca2017-10-30WarningsName fallback
brand name: SODIUM BICARBONATE
generic name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCe9698a4f-1a95-4f28-a945-e8009d1d6dd42017-09-27Warnings, Adverse reactionsName 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.