FDA.reportPublic FDA data

Application 018890

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METRONIDAZOLE IN PLASTIC CONTAINERMETRONIDAZOLEINJECTABLE;INJECTION500MG/100MLYesYes

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
N018890-002METRONIDAZOLE IN PLASTIC CONTAINERMETRONIDAZOLE500MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018890-002AP

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 22:54:322026-06N018890-002METRONIDAZOLE IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-11-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018890-002AP1a50c72e98297…

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 8 · 150 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.2f7d84d4-1085-4243-be88-442eecb852052026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
VagizoleMETRONIDAZOLEiNutrition LLCfd5e884b-cf07-493b-bb93-039bbb0c47842026-07-22Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack5cf3cc1f-601e-4997-bfb2-a573c31c81892026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.4a233572-2471-4e99-a45e-2de978abcf162026-07-15Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5a504f74-bccd-433a-bd5b-6822f98c34df2026-07-15Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5842a554-58d1-4ee4-99aa-1e6029a69be22026-07-15Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack4748ba37-9d66-497d-aa9f-ca2d541c5f412026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.59e53582-244a-4e9d-b18e-75dddc6a50522026-07-08Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.cfeab9e3-58b9-4890-9185-11b62904e2af2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.cbee69e8-029c-49d2-89cd-f504b8e0ac282026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.3e0a14f1-961b-4722-bfea-aafcc5d7706c2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.53918705-d2fe-4c6b-9501-a619a8ad39912026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEKanchan Healthcare Inc8836334e-6db4-44be-bc9e-099b26322cf42026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.49bed450-7fa8-401c-8c8c-afc1c61d473a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.3c0ebb00-a0ae-4f64-9bfc-de01193191e82026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLECoupler LLC545f2900-745c-c33c-e063-6294a90a5e4f2026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC4e1ac737-c353-4764-bd35-dc844e75b5622026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
METRONIDAZOLEMETRONIDAZOLESun Pharmaceutical Industries, Inc.7187779a-1f4c-4607-af53-4119e324aad52026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9911METRONIDAZOLEMETRONIDAZOLEHenry Schein, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811METRONIDAZOLEMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811METRONIDAZOLEMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
52584-811METRONIDAZOLEMETRONIDAZOLEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-811METRONIDAZOLEMETRONIDAZOLEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-811METRONIDAZOLEMETRONIDAZOLEGeneral Injectables and Vaccines, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81618SUPPL 2025-03-18
81611SUPPL 2025-03-17
79019SUPPL 2024-07-09
79006SUPPL 2024-07-09
75695SUPPL 2023-10-10
75688SUPPL 2023-10-10
69672SUPPL2021-12-20
69607SUPPL2021-12-17
66694SUPPL2021-03-09
66669SUPPL2021-03-09
53627SUPPL2018-04-05
53606SUPPL2018-04-04
33635SUPPL2015-07-16
16081SUPPL2015-07-14