FDA.reportPublic FDA data

NDC 0121-1075-55 - Brivaracetam

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
0121-1075
Requested NDC
0121-1075-55
Package NDCs from labels
0121-1075-55, 0121-1075-02
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2026-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Brivaracetam Injection - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2026-02-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1075-02Brivaracetam10 in 1 CARTONINJECTION103
0121-1075-55Brivaracetam5 mL in 1 VIAL, GLASSINJECTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1075-02ML - Milliliter0121-10758a945d93-06bf-4b7d-afee-68edd45f0d2e12026-03-17
0121-1075-55ML - Milliliter0121-1075090e2746-e68a-429f-9ced-820e01dc87c212026-03-17

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 10 of 56 · 1,107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Itch Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDEForces of Nature6131d921-c772-4684-b9ea-c5c8923daaf02026-02-25WarningsExact identifier
unii: 451W47IQ8X
BrivaracetamBRIVARACETAMApotex Corp.1915620d-4f37-56c2-437e-8362bb462d072026-02-25Warnings, Adverse reactionsExact identifier
unii: U863JGG2IA
BRIVARACETAMBRIVARACETAMMicro Labs Limitedc054a1c9-2aa7-473b-a04b-622596f36c952026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 1739749
unii: U863JGG2IA
Brivaracetam Oral SolutionBRIVARACETAMAscend Laboratories, LLCc4ee9b82-1067-4efc-b3d9-f24eb0c461d52026-02-24Warnings, Adverse reactionsExact identifier
unii: U863JGG2IA
BrivaracetamBRIVARACETAMNovadoz Pharmaceuticals LLC2c6af271-3222-4602-98a6-14754f0a29ba2026-02-23Warnings, Adverse reactionsExact identifier
rxcui: 1739749
unii: U863JGG2IA
BrivaracetamBRIVARACETAMHainan Poly Pharm. Co., Ltd.3ea51292-fe03-46f5-9d9b-36986f5b72242026-02-23Warnings, Adverse reactionsExact identifier
application number: ANDA218249
rxcui: 1739749
unii: U863JGG2IA
brivaracetamBRIVARACETAMZhejiang Poly Pharm. Co., Ltd.aef3ee92-e2a6-4135-94b2-b893f893d5f22026-02-23Warnings, Adverse reactionsExact identifier
unii: U863JGG2IA
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 451W47IQ8X
BrivaracetamBRIVARACETAM INJECTIONPAI Holdings, LLC dba PAI Pharma5bc0f4c0-8b31-4622-849f-d902be93788b2026-02-23Warnings, Adverse reactionsExact identifier
application number: ANDA218249
ndc (package): 0121-1075-02
ndc (package): 0121-1075-55
ndc (product): 0121-1075
ndc11 (package): 00121107555
rxcui: 1739749
spl id: c0702161-ae73-4aac-b6fd-fb3fa7c841b8
spl set id: 5bc0f4c0-8b31-4622-849f-d902be93788b
unii: U863JGG2IA
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
brivaracetamBRIVARACETAMNovadoz Pharmaceuticals LLCdca92c5b-78a8-4ee1-9f06-18320ae2a2e82026-02-19Warnings, Adverse reactionsExact identifier
unii: U863JGG2IA
Brivaracetam oral SolutionBRIVARACETAM ORALFlorida Pharmaceutical Products, LLC7957cc22-2e0f-489d-9fa1-99520f6159342026-02-17Warnings, Adverse reactionsExact identifier
unii: U863JGG2IA
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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