FDA.reportPublic FDA data

NDC 35561-357-26 - CARBAMAZEPINE ER

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
35561-357
Requested NDC
35561-357-26
Package NDCs from labels
35561-357-12, 35561-357-13, 35561-357-26, 35561-357-99
Manufacturer
Bostal LLC
Effective date
2026-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CARBAMAZEPINE ER - Bostal LLCBostal LLC2026-04-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35561-357-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-357-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-357-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35561-357-12CARBAMAZEPINE ER100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
35561-357-13CARBAMAZEPINE ER500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
35561-357-26CARBAMAZEPINE ER30 in 1 CARTONTABLET, EXTENDED RELEASE309
35561-357-99CARBAMAZEPINE ER33051 in 1 DRUMTABLET, EXTENDED RELEASE330519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-357CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [AUSTARPHARMA LLC]4Current NDC, Legacy NDC, 4 package rows20241027_b48741b3-0889-47b8-a26e-b12614f6e7fc.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 37 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
unii: 15FIX9V2JP
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
unii: 15FIX9V2JP
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
unii: 15FIX9V2JP
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
unii: 15FIX9V2JP
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
unii: 15FIX9V2JP
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
unii: 15FIX9V2JP
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
unii: 15FIX9V2JP
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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