FDA.reportPublic FDA data

NDC 67857-809-37 - ZEMBRACE SymTouch

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
67857-809
Requested NDC
67857-809-37
Package NDCs from labels
67857-809-37, 67857-809-38
Manufacturer
Promius Pharma, LLC
Effective date
2019-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZEMBRACE SymTouch - Promius Pharma, LLCPromius Pharma, LLC2019-06-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67857-809-382023-01-30C16284748780-1f386c649-a8cc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZEMBRACE™ SymTouch™ safely and effectively. See full prescribing information for ZEMBRACE™ SymTouch™. ZEMBRACE™ SymTouch™ (sumatriptan succinate) Injection, for subcutaneous use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67857-809-37ZEMBRACE SymTouch1 in 1 SYRINGEINJECTION, SOLUTION15
67857-809-38ZEMBRACE SymTouch4 in 1 CARTONINJECTION, SOLUTION45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67857-809ZEMBRACE SYMTOUCH (SUMATRIPTAN) INJECTION, SOLUTION [PROMIUS PHARMA, LLC]5Legacy NDC, 2 package rows20190626_d565763d-b740-411d-bbb4-13536017d634.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67857-809-37ML - Milliliter67857-809fe49d010-92f1-4d8c-99fb-0b34d0ad70f812016-04-04
67857-809-38ML - Milliliter67857-809f2a2905a-68c7-4cdc-a171-a0713dac074612016-04-04

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 4 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEFresenius Kabi USA, LLCb183c7ba-2cc6-4854-a9a6-71ccd35925862024-04-12Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANA-S Medication Solutionsf675d0db-f356-4eda-be62-b00af476326c2024-01-07Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATEA-S Medication Solutions97016a59-3b49-4134-85aa-8c866f2856012023-11-22Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENorthStar Rx LLC38fd19bf-b7aa-812c-8a74-2414dfec45f42023-03-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LP1042b91c-715c-4e90-b9cc-d91a17f9f7cb2022-04-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LP9f4d487a-c5f7-4707-976b-64e738c98d452022-04-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANSUN PHARMACEUTICAL INDUSTRIES, INC.c87cf537-9f7f-400e-ac4b-86e6f7e787752022-01-19Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limited4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b2021-12-21Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEXellia Pharmaceuticals USA LLCf42c6e00-e693-48f3-8e84-c3f139e1adf52021-11-18Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANSomerset Therapeutics, LLC53c62307-bd19-4418-b1b0-c0274b5595df2021-09-22Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANProficient Rx LP5cba3661-9b16-416b-b0c0-bbb12549d48f2021-01-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANProficient Rx LP121e36fb-471b-4318-bc47-b087ad68c6f72021-01-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANHikma Pharmaceuticals USA Inc.2b417f8c-9e5b-45a1-b8af-183818258df92021-01-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEAsclemed USA, Inc.b16886d0-224b-4d83-85c4-bc3eb3606c172020-10-24Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LPd556563f-ad71-45c1-829a-cc11983bce0c2020-03-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP68daf82a-334e-43ca-b4bb-5c66a82f52c82020-02-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP77a41cca-02d2-4b84-975e-d1925f0fca802019-11-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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