FDA.reportPublic FDA data

Vigabatrin

Product NDC
43598-697
11-digit product format
435980697
Labeler code
43598
Product ID
43598-697_108f12cf-4bfc-4406-1d50-d57e656f6c8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Inc.,
Application
ANDA211481
Marketing category
ANDA
Marketing start
2018-11-21
Substance
VIGABATRIN
Active strength
50 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vigabatrin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIGABATRIN50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGR120KRT6K
Rxcui250820

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
096748f0-965a-4afd-a326-9f691a2861e8Product name120250224
9dea3de0-6f03-9477-9f83-4ffb0883e43fProduct name620240507
9a8c6108-e754-40ae-a629-36a466ae0079Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-697-11Vigabatrin10 mL in 1 PACKETPOWDER, FOR SOLUTION108
43598-697-50Vigabatrin50 in 1 CARTONPOWDER, FOR SOLUTION508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-697-11EA - Each43598-697e83618cd-4502-453c-8709-47489a6c769812019-08-06
43598-697-50EA - Each43598-6979e54bd1e-9d80-4494-83cf-7010a988686e12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-697VIGABATRIN POWDER, FOR SOLUTION [DR. REDDY’S LABORATORIES INC.,]8Current NDC, Legacy NDC, 2 package rows20240608_f6be436e-46c7-e9ab-0fcf-e8d04dc12b72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250820vigabatrin 500 MG Powder for Oral SolutionPSNf6be436e-46c7-e9ab-0fcf-e8d04dc12b728
250820vigabatrin 500 MG Powder for Oral SolutionSCDf6be436e-46c7-e9ab-0fcf-e8d04dc12b728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-697-114359806971110 mL in 1 PACKET10 mlHistorical
43598-697-504359806975050 PACKET in 1 CARTON (43598-697-50) / 10 mL in 1 PACKET (43598-697-11) 50 packet2018-11-210000-00-00NoNoCurrent