FDA.reportPublic FDA data

vigabatrin for oral solution

Product NDC
31722-009
11-digit product format
317220009
Labeler code
31722
Product ID
31722-009_16ae8082-260c-b789-e063-6294a90ab6e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vigabatrin
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA213519
Marketing category
ANDA
Marketing start
2021-01-26
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 for oral solution
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
31722-009-50vigabatrin for oral solution50 in 1 CARTONPOWDER, FOR SOLUTION502
31722-009-50vigabatrin for oral solution10 mL in 1 PACKETPOWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-009-50EA - Each31722-009f822e0a9-cdf6-488c-af39-518292ecd3fd12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-009VIGABATRIN FOR ORAL SOLUTION (VIGABATRIN) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20240424_bda491b6-47ba-400b-9816-b6d15c6e2683.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250820vigabatrin 500 MG Powder for Oral SolutionPSNbda491b6-47ba-400b-9816-b6d15c6e26832
250820vigabatrin 500 MG Powder for Oral SolutionSCDbda491b6-47ba-400b-9816-b6d15c6e26832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-009-503172200095050 PACKET in 1 CARTON (31722-009-50) / 10 mL in 1 PACKET50 packet2021-01-260000-00-00NoNoCurrent