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 1 of 5 · 83 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
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
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2026-09-02Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEMylan Pharmaceuticals Inc.1d2cd01c-05e7-44cf-a71d-0f474e826b7e2026-08-26Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANSportpharm LLC865865ca-01df-4815-aa7e-2dfadc2c539d2026-07-23Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESportpharm LLC7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa2026-07-09Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.9485cc30-15e8-4b53-876d-db317145474b2026-06-25Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANBionpharma Inc.e90b0eea-c424-4f00-98da-6ed6e80de1f62026-05-29Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANArmas Pharmaceuticals Inc.65147b04-0b6b-4d30-9710-d5cdce85e8f52026-05-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEREMEDYREPACK INC.73c9ac06-b55e-41e0-90ec-deb250f37eb52026-05-19Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEAurobindo Pharma Limitedb2503fff-c978-4efa-b1b4-d7740b6b26f22026-05-12Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANA-S Medication Solutions7f34f450-d6f3-49a8-b55a-8e1e4a9ee9502026-05-11Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATESportpharm LLCd071aef6-a5bd-4f68-ba6d-03004466897c2026-04-24Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANGolden State Medical Supply, Inc.4b4915d3-be7a-e5fa-e063-6294a90a7f982026-04-23Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEGolden State Medical Supply, Inc.1bf70380-8272-4c0d-8841-d39ef27723512026-04-15Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANStrides Pharma Science Limited1909558d-8342-4af0-9487-eecdaac700702026-04-15Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limitedac80d018-6abf-2e41-ddea-90b4ff9e90132026-03-21Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptanSUMATRIPTANONESOURCE SPECIALTY PHARMA LIMITED587e6bb5-a665-4396-814e-ce893a20290b2026-02-20Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEA-S Medication Solutions62ba6fef-467a-4500-993c-51907f12a67c2026-02-14Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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