FDA.reportPublic FDA data

NDC 68071-3755-09 - Sumatriptan

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
68071-3755
Requested NDC
68071-3755-09
Package NDCs from labels
68071-3755-9, 68071-3755-09
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sumatriptan - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3755-9Sumatriptan1 in 1 CARTONTABLET11
68071-3755-9Sumatriptan9 in 1 BLISTER PACKTABLET91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3755SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250101_2a96f37d-03f6-678c-e063-6394a90ae0c6.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 1 of 17 · 325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.ff08b9ee-03bf-4f5b-930e-233a3b8866af2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2026-09-02Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 315223
unii: J8BDZ68989
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEMylan Pharmaceuticals Inc.1d2cd01c-05e7-44cf-a71d-0f474e826b7e2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
unii: 8MDF5V39QO
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
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
SumatriptanSUMATRIPTANSportpharm LLC865865ca-01df-4815-aa7e-2dfadc2c539d2026-07-23Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESportpharm LLC7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa2026-07-09Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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