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
Label	Manufacturer	Effective date	Type
ZEMBRACE SymTouch - Promius Pharma, LLC	Promius Pharma, LLC	2019-06-10	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67857-809-38	2023-01-30	C162847	48780-1	f386c649-a8cc-0266-e053-dadaa90a7c1a	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
67857-809-37	ZEMBRACE SymTouch	1 in 1 SYRINGE	INJECTION, SOLUTION	1		5
67857-809-38	ZEMBRACE SymTouch	4 in 1 CARTON	INJECTION, SOLUTION	4		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67857-809	ZEMBRACE SYMTOUCH (SUMATRIPTAN) INJECTION, SOLUTION [PROMIUS PHARMA, LLC]	5	Legacy NDC, 2 package rows	20190626_d565763d-b740-411d-bbb4-13536017d634.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67857-809-37	ML - Milliliter	67857-809	fe49d010-92f1-4d8c-99fb-0b34d0ad70f8	1	2016-04-04
67857-809-38	ML - Milliliter	67857-809	f2a2905a-68c7-4cdc-a171-a0713dac0746	1	2016-04-04

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 5 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d9c78ac5-7328-4204-8f66-96606d7db5c3	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: J8BDZ68989
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	44d6d757-489c-4262-a518-af8c470734d6	2019-10-01	Warnings, Adverse reactions	Exact identifier unii: J8BDZ68989
30c45ab6-7687-a85b-9f68-55198481dbad			d565763d-b740-411d-bbb4-13536017d634	2019-06-10	Warnings, Adverse reactions	Exact identifier spl id: 30c45ab6-7687-a85b-9f68-55198481dbad spl set id: d565763d-b740-411d-bbb4-13536017d634

Reported adverse events (FAERS/openFDA)#

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