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 2 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTAN SUCCINATENorthStar Rx LLC84bfc4ba-4172-4adb-b963-4e0eb438c07a2026-02-13Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptanSUMATRIPTANONESOURCE SPECIALTY PHARMA LIMITED4996682c-cd85-6e39-e063-6294a90a90ae2026-01-30Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptanSUMATRIPTANONESOURCE SPECIALTY PHARMA LIMITEDb4240c6e-6b9e-405f-82e6-a3d5bd9e6f292026-01-30Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Inc.0e8b65f7-9d3b-42f2-8d7e-69b1433659802026-01-29Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANBaxter Healthcare Corporationd13df081-648c-44c0-9854-5a1bfe23ae892026-01-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddys Laboratories Inc.,8fef1176-7a38-eca3-22ca-83efe5ca66202026-01-21Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.f235152e-dd8d-4679-9d9f-404fe5ff4fba2026-01-08Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
IMITREXSUMATRIPTANGlaxoSmithKline LLC584abe73-8290-4484-ff8e-5890831c095e2025-12-09Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
IMITREXSUMATRIPTANGlaxoSmithKline LLCfee7d073-0b99-48f2-7985-0d8cf970894b2025-12-09Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMNorthStar RxLLC3f2ec27e-0e96-4028-a1fa-114e6d5014642025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Limited16b7e44d-afa0-4177-80ef-c3ae9a78a4e12025-11-17Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANEugia US LLCc009976a-4e29-4aeb-9e55-a88766ebb1fb2025-11-12Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMSun Pharmaceutical Industries, Inc.96ed12a3-fa76-4afd-bee8-1ab19eb607f32025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.f2e7d756-1e12-462a-a43f-a9d860b11ee82025-09-25Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANEugia US LLC9b1bb8c9-be3a-47c3-b3bc-9c983cde7d232025-05-29Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptanSUMATRIPTANRising Pharma Holdings, Inc.352d2ab3-d2c7-48c8-bcd4-d46ed9bdfa852025-05-21Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Zembrace SymTouchSUMATRIPTAN SUCCINATETonix Medicines, Inc.3eb49807-fa9d-4a0d-9a3c-76de5b23b01b2025-02-28Warnings, Adverse reactionsExact identifier
application number: NDA208223
rxcui: 1738576
rxcui: 1738581
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2efd4269-5657-9669-e063-6394a90a583a2025-02-25Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANNuCare Pharmaceuticals,Inc.082d05f6-3850-0fa2-e063-6294a90a0c662025-02-03Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANDirect_Rxefb7ec4e-0a5d-2aae-e053-2a95a90aebf22025-01-22Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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