FDA.reportPublic FDA data

NDC 0245-0144-89 - 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
0245-0144
Requested NDC
0245-0144-89
Package NDCs from labels
0245-0144-30, 0245-0144-11, 0245-0144-89, 0245-0144-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pacerone - Bryant Ranch PrepackBryant Ranch Prepack2025-11-05HUMAN PRESCRIPTION DRUG LABEL
Pacerone - Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals Inc.Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals Inc.2025-07-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0144-01Pacerone100 in 1 CARTONTABLET10027
0245-0144-11Pacerone100 in 1 BOTTLETABLET10027
0245-0144-30Pacerone30 in 1 BOTTLETABLET3027
0245-0144-89Pacerone1 in 1 BLISTER PACKTABLET127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0144PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, LLC]26Current NDC, Legacy NDC, 4 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
0245-0144-01EA - Each0245-014452ac0ee2-5185-411c-baca-b8a4feed9aa612012-07-24
0245-0144-30EA - Each0245-01449f3788cb-5e7b-41a0-9e41-41aafe6fc93612012-07-24
0245-0144-89EA - Each0245-014438528244-7dc8-4200-b346-5bc4d32b0e0d12013-02-13

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 4 of 6 · 117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEProPharma Distribution364ab45e-b525-f310-e063-6394a90a44212025-12-17Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAdvagen Pharma Limitedd911b4cf-eec4-43f8-aa64-cc60cfc901b92025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
rxcui: 834348
rxcui: 835956
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEChartwell RX, LLC5520f11d-968d-4f4f-bf57-d14369c0d7462025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
rxcui: 834348
rxcui: 835956
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAmerican Health Packagingd912a75a-ddac-4e7b-b5c4-321d4252ec052025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z
PaceroneAMIODARONE HYDROCHLORIDEBryant Ranch Prepackdcadce9c-d0a0-4235-8ff8-dd93c09e03b32025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075135
ndc (package): 72162-2148-3
ndc (product): 72162-2148
rxcui: 835958
rxcui: 835956
spl id: b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0
spl set id: dcadce9c-d0a0-4235-8ff8-dd93c09e03b3
unii: 976728SY6Z
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHenry Schein, Inc.0c9ee15a-5741-4aaa-8d80-c7bd2e45822e2025-10-29Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC.4240b2e9-be05-3de5-e063-6394a90a4bb22025-10-28Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
PaceroneAMIODARONE HYDROCHLORIDEUpsher-Smith Laboratories, LLC4c4ec9b0-13a5-49a8-b57b-b3f64e4316a72025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075135
ndc (package): 0245-0147-89
ndc (package): 0245-0144-11
ndc (package): 0245-1645-89
ndc (package): 0245-0147-60
ndc (package): 0245-0147-01
ndc (package): 0245-0144-01
ndc (package): 0245-0144-89
ndc (package): 0245-0144-30
ndc (package): 0245-0147-15
ndc (package): 0245-1645-30
ndc (package): 0245-0147-90
ndc (package): 0245-1645-01
ndc (product): 0245-0147
ndc (product): 0245-1645
ndc (product): 0245-0144
ndc11 (package): 00245014489
rxcui: 834346
rxcui: 833528
rxcui: 834348
rxcui: 835958
rxcui: 834350
rxcui: 835956
spl id: 39e7666b-4916-2716-e063-6394a90a0589
spl set id: 4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDESlate Run Pharmaceuticals3a53668c-adda-44c2-a743-e79e467437e32025-04-01Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEFresenius Kabi USA, LLCd8d04647-8e25-4127-8ecf-360ce1991c2f2025-03-31Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEFresenius Kabi USA, LLC9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a2025-03-06Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Lifesciences Limited3e8db251-e3c5-4fba-be9a-6044a92f0beb2024-11-25Exact identifier
rxcui: 833528
rxcui: 834348
rxcui: 835956
unii: 976728SY6Z
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsd42293e9-07fa-41b4-a08b-2e388f5b1e132024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833528
unii: 976728SY6Z

Reported adverse events (FAERS/openFDA)#

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