FDA.reportPublic FDA data

NDC 10631-488 - Isoptin SR

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
10631-488
Package NDCs from labels
10631-488-01
Manufacturer
Ranbaxy Laboratories Inc.
Effective date
2008-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isoptin SR - Ranbaxy Laboratories Inc.Ranbaxy Laboratories Inc.2008-03-11HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10631-488-01Isoptin SR100 in 1 BOTTLETABLET, COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10631-488ISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]11 package rows20080521_6ae13cb4-0316-40d1-9216-c7d5556aaed3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-488-01EA - Each10631-48897ccb1dd-ad95-4c29-9b6f-7b3be9b3cbdc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Verapamil hydrochlorideACTIVE INGREDIENTV3888OEY5RISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
VerapamilACTIVE MOIETYCJ0O37KU29ISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
AlginateINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
D&C yellow#10 Lake dyeINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
FD&C blue#2 Lake dyeINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
HypromelloseINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
Iron oxideINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30ISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
Microcrystalline celluloseINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
Polyethylene glycolINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
Polyvinyl pyrrolidoneINACTIVE INGREDIENTISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPISOPTIN SR (VERAPAMIL HYDROCHLORIDE) TABLET, COATED [RANBAXY LABORATORIES INC.]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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.febce7aa-7f5a-e0c1-e053-6394a90aebc42025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 897659
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d23c757d-39f8-48c3-ba63-df2cbe58c5162025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 897659
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.fdb7cd57-d33c-f5a3-e053-6294a90aff312024-12-13Warnings, Adverse reactionsExact identifier
rxcui: 897640
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEA-S Medication Solutions0b00ec93-0bb3-4181-a6ef-45206f0621f72024-10-16Warnings, Adverse reactionsExact identifier
rxcui: 897659
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals, Inc.3f14442c-8178-0bad-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
rxcui: 897649
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.a58f5f77-7e88-d622-e053-2a95a90a0d352024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 897640
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch Prepackf88dfe56-08bc-46b1-8f05-f886a16a89bc2024-07-08Warnings, Adverse reactionsExact identifier
rxcui: 897659
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch Prepack2f839b5c-b8e7-40df-887f-7df94326fc7b2023-12-08Warnings, Adverse reactionsExact identifier
rxcui: 897649
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEProficient Rx LP343724eb-e80b-4729-80e7-6b8028713ea12023-05-01Warnings, Adverse reactionsExact identifier
rxcui: 897640
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC2712ab16-122b-4f44-a687-e2cb3c04019e2020-04-09Warnings, Adverse reactionsExact identifier
rxcui: 897640
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LP19cb23bd-cc6d-45fc-a1fc-b4130ea460a62019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 897659
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LP4ffa579e-1d85-4b3b-ae06-6a9334e0f9e12019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 897649
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc635f442-2349-4820-877a-a42e5f0a44b52019-05-08Warnings, Adverse reactionsExact identifier
rxcui: 897649
6C6C239F-2CC5-CA9C-C2FF-14A9D1EEB6D56ae13cb4-0316-40d1-9216-c7d5556aaed32008-03-11Warnings, Adverse reactionsExact identifier
spl id: 6C6C239F-2CC5-CA9C-C2FF-14A9D1EEB6D5
spl set id: 6ae13cb4-0316-40d1-9216-c7d5556aaed3

Reported adverse events (FAERS/openFDA)#

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