FDA.reportPublic FDA data

NDC 70771-1368-2 - COLESEVELAM

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
70771-1368
Requested NDC
70771-1368-2
Package NDCs from labels
70771-1368-8, 70771-1368-0, 70771-1368-2, 70771-1368-4
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COLESEVELAM - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-11-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70771-1368-02024-09-04COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-42024-09-04COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-82024-09-04COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-02024-01-30COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-42024-01-30COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-82024-01-30COLESEVELAM HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1368-0COLESEVELAM1000 in 1 BOTTLETABLET10005
70771-1368-2COLESEVELAM10 in 1 BLISTER PACKTABLET105
70771-1368-4COLESEVELAM10 in 1 CARTONTABLET105
70771-1368-8COLESEVELAM180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1368COLESEVELAM TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 4 package rows20241130_090eabd5-acd3-43ed-a05b-52f1f3773a93.zip

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 7 of 184 · 3,670 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTOR INKS IPA WIPESISOPROPYL ALCOHOLEnviro Specialty Chemicals Incf65f0ec4-fa2c-487d-a8cc-41cbb8c140a42026-07-24WarningsExact identifier
unii: ND2M416302
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
unii: ND2M416302
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
unii: ND2M416302
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
unii: ND2M416302
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Colesevelam HCLCOLESEVELAM HCLBryant Ranch Prepack5d1b8dfd-cfe7-4c86-9d7b-a709b593acf72026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 866910
unii: P4SG24WI5Q

Reported adverse events (FAERS/openFDA)#

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