FDA.reportPublic FDA data

NDC 63629-1944-01 - Felbamate

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
63629-1944
Requested NDC
63629-1944-01
Package NDCs from labels
63629-1944-1, 63629-1944-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Felbamate - Bryant Ranch PrepackBryant Ranch Prepack2025-03-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1944-1Felbamate100 in 1 BOTTLETABLET100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1944FELBAMATE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20250321_3170233c-0452-4150-9e4c-dfffcde7424e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1944-1EA - Each63629-19449696070e-1525-4980-9e4e-e69c56794f7b12021-03-02

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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FelbamateFELBAMATESun Pharmaceutical Industries, Inc.0afffb17-e6ac-4bea-a90e-7ef3c81502902026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X72RBB02N8
FelbamateFELBAMATESun Pharmaceutical Industries, Inc.f2edb3ed-da20-4093-88ea-00fe781e47e02026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
FelbamateFELBAMATEAmneal Pharmaceuticals of New York LLC1aa40de5-c02d-49d6-8722-ed88c40c3ba62026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
FelbamateFELBAMATEBryant Ranch Prepack6afd77f2-4525-42f4-a4b1-94159c401dd22026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202284
rxcui: 198358
unii: X72RBB02N8
FelbamateFELBAMATEBryant Ranch Prepackd6eaf094-09e2-480c-bea9-7a2768aad8842026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202284
rxcui: 198358
unii: X72RBB02N8
FelbamateFELBAMATEBryant Ranch Prepack696e3cbb-a431-4f29-acbd-1db8e9aaef932026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202284
rxcui: 198359
unii: X72RBB02N8
FelbamateFELBAMATEViona Pharmaceuticals Inc96f4357c-720c-4651-b638-7b1181531dc52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
FelbamateFELBAMATEANI Pharmaceuticals, Inc.17850520-f823-4d05-8f9b-5eadfa68bae22025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202284
ndc (product): 62559-731
rxcui: 198359
rxcui: 198358
spl id: 76100661-b064-4f19-b9ba-8ba4adcf042f
spl set id: 17850520-f823-4d05-8f9b-5eadfa68bae2
unii: X72RBB02N8
FelbatolFELBAMATEViatris Specialty LLC2f522701-397a-11de-8a39-0800200c9a662025-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
FelbamateFELBAMATEBryant Ranch Prepack3170233c-0452-4150-9e4c-dfffcde7424e2025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202284
ndc (package): 63629-1944-1
ndc (product): 63629-1944
ndc11 (package): 63629194401
rxcui: 198359
spl id: 27426bc1-4084-4e2f-a06f-05830677d2a3
spl set id: 3170233c-0452-4150-9e4c-dfffcde7424e
unii: X72RBB02N8
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
FelbamateFELBAMATEAmneal Pharmaceuticals LLC2e325d79-d0a4-4af7-b09b-96ee5a5b2a372024-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X72RBB02N8
FelbamateFELBAMATEAmneal Pharmaceuticals LLCaa3fd2c0-98d6-45f3-81b0-a902526214c62024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
FelbamateFELBAMATEZydus Lifesciences Limitedefa55cb2-b625-4392-9ddb-0a8ad8ee58c42024-08-16Exact identifier
rxcui: 198359
rxcui: 198358
unii: X72RBB02N8
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
FelbamateFELBAMATENovitium Pharma LLC81c8a2e1-732c-4467-84e9-53fef1655ee22022-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X72RBB02N8

Reported adverse events (FAERS/openFDA)#

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