NDC 80789-117-01 - VIGPODER

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: 80789-117
Requested NDC: 80789-117-01
Package NDCs from labels: 80789-117-01, 80789-117-50
Manufacturer: Pyros Pharmaceuticals, Inc.
Effective date: 2024-12-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
VIGPODER - Pyros Pharmaceuticals, Inc.	Pyros Pharmaceuticals, Inc.	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80789-117	VIGPODER (VIGABATRIN) POWDER, FOR SOLUTION [PYROS PHARMACEUTICALS, INC.]	7	Unmatched	20241215_1859a632-e98e-4152-b91d-b8aae1107be1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80789-117-01	EA - Each	80789-117	b88cd2db-fb0f-4264-a048-0fdd07653ece	1	2024-01-04
80789-117-50	EA - Each	80789-117	82bf1d10-7e11-4955-8a21-922d0f63467c	1	2024-01-04

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vigabatrin	VIGABATRIN	Hikma Pharmaceuticals USA Inc	5ed8d293-b7d8-4c66-9c31-8075e6f99092	2022-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GR120KRT6K
VIGABATRIN	VIGABATRIN	Cipla USA, Inc.	823cc915-0350-4780-85ed-cd1c338e429d	2022-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GR120KRT6K
SABRIL	VIGABATRIN	Lundbeck Pharmaceuticals LLC	a5d389d2-d0e1-4395-a2a2-b552808e7f98	2021-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GR120KRT6K
SABRIL	VIGABATRIN	Lundbeck Pharmaceuticals LLC	a88ac1b4-e2c9-45c0-b321-4785902172e3	2021-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GR120KRT6K
Vigabatrin	VIGABATRIN	Dr. Reddys Laboratories Inc.,	0afdc84c-f8ec-330a-31c9-fac4ed256931	2020-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GR120KRT6K

Reported adverse events (FAERS/openFDA)#

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