FDA.reportPublic FDA data

Application 018686

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORMODYNELABETALOL HYDROCHLORIDEINJECTABLE;INJECTION5MG/MLYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018686-001NORMODYNELABETALOL HYDROCHLORIDE5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-08-01

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018686-001NORMODYNE5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-08-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018686-001NORMODYNE5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-08-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018686-001NORMODYNE5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-08-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018686-001NORMODYNE5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-08-01a50c72e98297…

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 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC63db5b00-e864-4b2d-84f2-00bf35211b9b2026-09-04Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.e2e50571-d8c1-43e7-b90f-877ba1c35c9b2026-08-31Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECoupler LLC5954cc5c-3e73-e039-e063-6394a90a7d6a2026-08-18Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEOnesource Specialty Pharma Limited6cb2c117-584c-4440-acfb-e4b1af4dc5092026-06-29Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDESt. Mary's Medical Park Pharmacyed2293f8-2b82-c3db-e053-2995a90ad46c2026-06-22Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.5101b8dd-6148-465c-9bba-0209ce823fe52026-06-11Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBluePoint Laboratories Inc.63ede355-42ec-4c52-a941-51e5f6b35ed62026-06-08Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack9c3bb751-c425-43ff-b530-2460b568b6892026-06-05Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionsfffb7c59-ad92-4e74-850d-d94d42b7fdc92026-06-04Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBluePoint Laboratoriese4562c70-f245-4dbe-8fe1-0bb64a91a3152026-06-04Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC1b96ddc9-d0c3-488a-a113-66491fd3d8992026-06-03Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEBryant Ranch Prepack04f9dcdf-4023-48ee-9e7d-ca9366d9db722026-05-22Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLCd3ca153c-25b2-4506-91bd-bf9d6a4c01fe2026-05-19Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackc0c1a162-cd30-4ac9-bc62-407493ed54a52026-05-11Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEProficient Rx LP54b75509-824b-4291-818d-71dc1b88915f2026-05-01Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEGolden State Medical Supply, Inc.d5ce687f-4a37-d3e6-e053-2995a90aa9742026-04-16Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions371cb135-6a5f-433d-a87d-ab8521c4aa6d2026-04-16Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsf9af85d3-a5a7-49d6-aff6-1ca2b2d754502026-04-16Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENorthStar Rx LLC5bd81a8a-a480-4c8d-bd4f-3158412e6a732026-04-13Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEREMEDYREPACK INC.ae5d7b3b-e444-48d3-9d85-9b07319f93742026-04-10Warnings, Adverse reactionsName fallback
generic name: LABETALOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.