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#

Related label table
Related label
Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
Carbamazepine 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 93 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight SunscreenTITANIUM DIOXIDECosmetique Active Productionacb887bc-7e46-4257-9fe3-a2cade6c4f382023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Solar Defense TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ec4-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Solar Defense Non TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ea1-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Erborian BB creme au Ginseng chocolate SPF 20OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lddcd6ea4-e7b1-88df-e053-2a95a90a99232023-12-09WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lcb23ba95-1e83-4523-a35c-3b70c0605dd12023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.ac2d5713-9955-477e-a10f-e8a1191b5fdd2023-12-07WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1720cff-a897-68cb-e053-2995a90a30b62023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4ed-2212-e053-2995a90add372023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4f0-2212-e053-2995a90add372023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228ca6-8fb4-5964-e053-2a95a90a30ca2023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12292a8-c98f-eb27-e053-2a95a90a9bbc2023-12-05WarningsExact identifier
unii: 15FIX9V2JP
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skinTITANIUM DIOXIDE, ZINC OXIDERodan & Fieldsb7401ff8-ca47-4c74-813c-99c5f28c0b6d2023-12-04WarningsExact identifier
unii: 15FIX9V2JP
Perbelle CC SPF43 UVA UVB Broad SpectrumTITANIUM DIOXIDEPerbelle Cosmetics Global Ltd.b5e2724e-9806-5bcc-e053-2a95a90a05082023-12-01WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228d15-a157-6989-e053-2995a90a44ea2023-12-01WarningsExact identifier
unii: 15FIX9V2JP
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
unii: 15FIX9V2JP
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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