FDA.reportPublic FDA data

Application 202563

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202563-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2012-08-20
A202563-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2012-08-20

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
2026-08-01 22:54:322026-06A202563-001CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTION2012-08-20a50c72e98297…
2026-08-01 22:54:322026-06A202563-002CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTION2012-08-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLCddbc3bf6-5bab-4851-ae5a-ef263cd8f2552026-07-23Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC86ec0a92-a552-4a6d-9125-a54f95e433922026-06-18Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC85ce4f8b-77e0-48bf-9f57-93f1478befa22026-04-24Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC9a937e47-8c36-4656-83e1-b3c18ed9bac32026-04-24Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMREMEDYREPACK INC.9c801096-ca61-4b29-a1e1-5f7e7813b1912026-02-06Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMQilu Pharmaceutical Co., Ltd.4cdf0743-c62b-4969-b9c9-4c6400644f6c2026-02-04Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc128bb292-d174-4769-b3e6-9f16617f31e32026-01-22Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc19141ccd-e66c-49a2-a794-0616028495a72026-01-19Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc03283208-8616-4117-9d2b-aa8046017a4f2026-01-19Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc365fc265-8e6c-432f-9fda-911f5f7fb4512026-01-16Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc36c07ebf-b091-483e-b2c4-f0fc0c2b41862026-01-16Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC7bed9b33-29e3-4f04-9766-43a21c7ad47a2026-01-07Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
CeftriaxoneCEFTRIAXONEWG Critical Care, LLCbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff02025-04-07Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Inc53df951b-2eee-44b1-bae2-df7ed85bc0ed2025-02-28Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Incde028434-46cf-44f6-8ac6-889c7c6943b32025-02-27Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONE SODIUMBaxter Healthcare Company4c5c2d3f-5038-41a1-a2fe-4dcd048dbac12024-10-07Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions53415af6-4072-4339-83e2-d870ae02a0e22024-08-20Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutionsb642877e-0d36-4218-afe9-0a39f35b571d2024-03-27Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONECivica, Inc.96f3fc1e-84f4-4e9b-91ac-19a1692f227a2024-02-06Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP790279d4-2456-4091-abec-960b788854322024-02-01Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM