FDA.reportPublic FDA data

Application 076978

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINERONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.64MG BASE/MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076978-001ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINERONDANSETRON HYDROCHLORIDEEQ 0.64MG BASE/MLINJECTABLE / INJECTION2007-02-26

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 22:54:322026-06A076978-001ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINEREQ 0.64MG BASE/MLINJECTABLE / INJECTION2007-02-26a50c72e98297…

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy57b0a1e5-5dfa-64a0-e063-6394a90acf362026-07-24Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ondansetronONDANSETRON HYDROCHLORIDEAscend Laboratories, LLC2edc0788-dc38-4d21-ba8e-71f159e2d3b12026-07-22Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ondansetronONDANSETRON HYDROCHLORIDECardinal Health 107, LLCcb02f2d7-31a9-4f12-880e-7ce7d85440d42026-07-17Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepack3f2e8efe-7fd4-407c-a77b-bd6dd04608e22026-07-10Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.ee3e8cbe-4f0b-4361-a1b5-8329d85a29322026-07-08Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.561dce26-92fa-e00b-e063-6294a90a1ab22026-07-08Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEProficient Rx LP0a14eb9a-0385-40e9-a7ec-71435450ac912026-07-01Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.5566aebb-d84d-6d6a-e063-6294a90a746f2026-06-29Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy58f16a00-3e66-29de-e053-2991aa0a59a02026-06-26Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAmerican Health Packaging9f015e60-1aec-4ae7-b28f-42f6c8f504552026-06-25Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECoupler LLC546191d2-d092-6342-e063-6294a90a0cd32026-06-16Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy00b17a8e-9d38-a8d4-e063-6294a90a153e2026-06-15Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDERedpharm Drug541b9a0d-ae94-db6f-e063-6394a90a98052026-06-12Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESportpharm LLCc0be25a0-e13d-4242-93dc-0b86e82aadd72026-04-24Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.5cc67d95-6629-4451-9e34-2f7a60482be52026-04-10Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESportpharm LLCb1324076-f83e-4816-9e02-6b2a689010bc2026-04-05Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepacke2c0e86c-e7fc-48f9-a894-02da8761001c2026-03-05Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEA-S Medication Solutionse0f69f57-aeb9-4890-85aa-e5976208e8be2026-02-12Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDECardinal Health 107, LLC30107d6f-5128-484f-b713-65244a98dc672026-01-14Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.7e862601-1d8a-455b-8ce5-1a32478b309f2026-01-07Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE