FDA.reportPublic FDA data

NDC 58670-001 - Antiemetic Gastrokinetic PILERAN

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
58670-001
Package NDCs from labels
58670-001-20
Manufacturer
Holliday-Scott S.A. | Ipca Laboratories Limited
Effective date
2013-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METOCLOPRAMIDE HYDROCHLORIDE - Holliday-Scott S.A. | Ipca Laboratories LimitedHolliday-Scott S.A. | Ipca Laboratories Limited2013-07-18OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58670-001-20Antiemetic Gastrokinetic PILERAN1 in 1 CARTONSOLUTION11
58670-001-20Antiemetic Gastrokinetic PILERAN20 mL in 1 BOTTLE, DROPPERSOLUTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58670-001ANTIEMETIC GASTROKINETIC PILERAN (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]12 package rows20130718_923d6054-9409-464c-8083-4cee81f6ccb4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDANTIEMETIC GASTROKINETIC PILERAN (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46ANTIEMETIC GASTROKINETIC PILERAN (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]1

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 3 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDEMylan Institutional Inc.447dbb34-7903-4e6a-be31-48a0b0e0d2f52025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDECardinal Health 107, LLC55b3fecb-f60c-474b-9530-915b0e68bf852025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEANI Pharmaceuticals, Inc.4e12e98a-06fe-4b3c-bb64-f2701e195c742025-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDENCS HealthCare of KY, LLC dba Vangard Labs4ab8ddab-8226-4b5a-8774-308ed49d6bc42025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack9530014b-c266-4015-9195-9f100d67317b2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDECardinal Health 107, LLC917494a9-cff1-4ee6-9523-e112120373c52025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3cc8ca5b-8b71-4c77-a181-9ce154597b9a2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEAmerican Health Packaging998f1782-bbfa-469b-9fe1-c612e8588f702024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.40cf021d-5f2a-055c-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals,Inc.5d7cd5a0-4a84-4084-e053-2a91aa0a686f2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.46dcafbc-9d50-316a-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack23f11d3c-1529-4bb6-a61e-e4bab1a3e98e2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEGenus Lifesciences Inc.74358569-7a24-4a59-a7fc-500d2341d6cb2024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack6f0a13cc-9346-4f4a-9a0d-b725045b01aa2024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
METOCLOPRAMIDEMETOCLOPRAMIDEHF Acquisition Co LLC, DBA HealthFirst7678bcd5-1071-0a9b-e053-2a91aa0a38532024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack31da0c8b-8171-4bd2-9832-12ba85e36b372024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEFresenius Kabi USA, LLCcc739885-e10e-4bcb-a781-c726c518f3d12023-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEMedical Purchasing Solutions, LLC79754097-4514-297e-e053-2991aa0a48042023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLCd163182b-582d-df59-e053-2995a90a300b2023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD
MetoclopramideMETOCLOPRAMIDEA-S Medication Solutions264c4f48-51f4-458f-9e61-1adafdf604fc2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W1792A2RVD

Reported adverse events (FAERS/openFDA)#

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