FDA.reportPublic FDA data

NDC 42043-221-00 - 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
42043-221
Requested NDC
42043-221-00
Package NDCs from labels
42043-221-00, 42043-221-09
Manufacturer
Quality Care Products, LLC
Effective date
2022-08-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sumatriptan - Quality Care Products, LLCQuality Care Products, LLC2022-08-18HUMAN PRESCRIPTION DRUG LABEL
SumatriptanOrchidPharma Inc | Orchid Pharma Ltd. | Orchid Helathcare (A Division of Orchid Pharma Limited)2022-01-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42043-221-092024-12-23C16284748780-10191ceaa-6c93-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets, for oral use Initial U.S. Approval: 1992
42043-221-092023-07-28C16284748780-10191ceaa-6c93-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets, for oral use Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42043-221-00EA - Each42043-22143041c86-4148-49ea-8009-7e610ebeb36012020-08-06
42043-221-09EA - Each42043-221ab81dbb4-5075-4c90-8ecf-15337799ecec12020-08-06

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 127 · 2,522 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.ff08b9ee-03bf-4f5b-930e-233a3b8866af2026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA078284
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612026-09-03Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2026-09-02Warnings, Adverse reactionsExact identifier
application number: ANDA078284
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2026-09-02Warnings, Adverse reactionsExact identifier
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
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEMylan Pharmaceuticals Inc.1d2cd01c-05e7-44cf-a71d-0f474e826b7e2026-08-26Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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