FDA.reportPublic FDA data

NDC 0245-1645-89 - Pacerone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0245-1645
Requested NDC
0245-1645-89
Package NDCs from labels
0245-1645-30, 0245-1645-89, 0245-1645-01
Manufacturer
Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals Inc.
Effective date
2025-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pacerone - Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals Inc.Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals Inc.2025-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-1645-01Pacerone100 in 1 CARTONTABLET10027
0245-1645-30Pacerone30 in 1 BOTTLETABLET3027
0245-1645-89Pacerone1 in 1 BLISTER PACKTABLET127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-1645PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, LLC]26Current NDC, Legacy NDC, 3 package rows20230602_4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-1645-89EA - Each0245-1645e9264d7b-ff52-4d8b-b8d2-02d60df7ff2512025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
AmiodaroneACTIVE MOIETYN3RQ532IUTPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
magnesium stearateINACTIVE INGREDIENT70097M6I30PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
povidonesINACTIVE INGREDIENTFZ989GH94EPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
starch, cornINACTIVE INGREDIENTO8232NY3SJPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
stearic acidINACTIVE INGREDIENT4ELV7Z65APPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16

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 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.4c149392-a4f0-4e2d-a13f-2b94810005de2026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDERedpharm Drug57f7f2ea-4ca9-4ada-e063-6294a90a492b2026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.51a88e8e-da02-4b97-9e7e-442fbffd908d2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
amiodarone hydrochlorideAMIODARONE HYDROCHLORIDESafecor Health LLCf49d011f-5ca6-4f75-ba16-2099fe42f5aa2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEBryant Ranch Prepackf3e631c5-1204-419c-8dbe-fa9b37a77f972026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEBryant Ranch Prepackf4532f12-3b7a-42ab-9a6c-36fd2a3f192c2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMajor Pharmaceuticalsb8bf4aa2-abea-403d-a6d9-395caf5f87f02026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEDr. Reddy's Labratories Inc.95cef33b-c0e6-b17c-7cbb-f5c0668727052026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
rxcui: 834348
rxcui: 835956
unii: 976728SY6Z
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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