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 3 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c95873-576d-a1c2-e053-6294a90a3ff92025-01-22Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c907a3-9624-f893-e053-6294a90a31af2025-01-22Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.7628caf4-5272-4e42-e053-2a91aa0a2f242025-01-08Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANProficient Rx LP85bf8e58-0984-427b-9ed4-7e0df4e444d22025-01-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLCf1a118cf-2179-572a-e053-2995a90acbb02024-12-31Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf27ca3c0-9de0-ff9c-e053-2a95a90ab8942024-12-31Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLC2aab8786-b225-833a-e063-6394a90ac7ae2024-12-30Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan Succinate and Naproxen SodiumSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven5762bbe6-bddf-495c-adf8-9096f98a3a9c2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
TreximetSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC42ddf376-8dc0-4236-be2a-0c6ae92ece042024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMAurobindo Pharma Limitedf5203c66-0a40-4263-a237-b71e930e46972024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rx284ee7ac-759e-b592-e063-6394a90a78ba2024-12-02Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANA-S Medication Solutions790acc89-81b3-4869-92e7-dc9f7fa6567b2024-11-08Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANCaplin Steriles Limited01293e09-d49a-411d-9647-6f23318ac2012024-09-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf8c4bbfb-1586-4610-e053-6394a90a8f092024-08-27Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.b297a466-7d24-9ebd-e053-2a95a90af4d12024-07-17Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Exact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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