FDA.reportPublic FDA data

ZUNVEYL

Product NDC
84054-005
11-digit product format
840540005
Labeler code
84054
Product ID
84054-005_4d40eab5-38f7-69a6-e063-6394a90a7fbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzgalantamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Alpha Cognition, Inc.
Application
NDA218549
Marketing category
NDA
Marketing start
2024-08-09
Substance
BENZGALANTAMINE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZUNVEYL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZGALANTAMINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXOI2Q0ZF7G
Rxcui2690632, 2690638, 2690640, 2690642, 2690644, 2690646

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa65c9a6-8447-49dd-a054-94f8aac21ce8Product name120250311

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84054-005-14ZUNVEYL14 in 1 BOTTLETABLET, DELAYED RELEASE145
84054-005-60ZUNVEYL60 in 1 BOTTLETABLET, DELAYED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84054-005ZUNVEYL (BENZGALANTAMINE) TABLET, DELAYED RELEASE [ALPHA COGNITION, INC.]4Current NDC, 2 package rows20250221_af47bf67-1f07-4650-8064-24c38afc4656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690640benzgalantamine 10 MG Delayed Release Oral TabletPSNaf47bf67-1f07-4650-8064-24c38afc46565
2690644benzgalantamine 15 MG Delayed Release Oral TabletPSNaf47bf67-1f07-4650-8064-24c38afc46565
2690632benzgalantamine 5 MG Delayed Release Oral TabletPSNaf47bf67-1f07-4650-8064-24c38afc46565
2690642ZUNVEYL 10 MG Delayed Release Oral TabletPSNaf47bf67-1f07-4650-8064-24c38afc46565
2690646ZUNVEYL 15 MG Delayed Release Oral TabletPSNaf47bf67-1f07-4650-8064-24c38afc46565
2690638ZUNVEYL 5 MG Delayed Release Oral TabletPSNaf47bf67-1f07-4650-8064-24c38afc46565
2690642benzgalantamine 10 MG Delayed Release Oral Tablet [Zunveyl]SBDaf47bf67-1f07-4650-8064-24c38afc46565
2690646benzgalantamine 15 MG Delayed Release Oral Tablet [Zunveyl]SBDaf47bf67-1f07-4650-8064-24c38afc46565
2690638benzgalantamine 5 MG Delayed Release Oral Tablet [Zunveyl]SBDaf47bf67-1f07-4650-8064-24c38afc46565
2690640benzgalantamine 10 MG Delayed Release Oral TabletSCDaf47bf67-1f07-4650-8064-24c38afc46565
2690644benzgalantamine 15 MG Delayed Release Oral TabletSCDaf47bf67-1f07-4650-8064-24c38afc46565
2690632benzgalantamine 5 MG Delayed Release Oral TabletSCDaf47bf67-1f07-4650-8064-24c38afc46565
2690640benzgalantamine 10 MG (equivalent to benzgalantamine gluconate 14.98 MG) Delayed Release Oral TabletSYaf47bf67-1f07-4650-8064-24c38afc46565
2690644benzgalantamine 15 MG (equivalent to benzgalantamine gluconate 22.47 MG) Delayed Release Oral TabletSYaf47bf67-1f07-4650-8064-24c38afc46565
2690632benzgalantamine 5 MG (equivalent to benzgalantamine gluconate 7.49 MG) Delayed Release Oral TabletSYaf47bf67-1f07-4650-8064-24c38afc46565
2690642Zunveyl 10 MG Delayed Release Oral TabletSYaf47bf67-1f07-4650-8064-24c38afc46565
2690646Zunveyl 15 MG Delayed Release Oral TabletSYaf47bf67-1f07-4650-8064-24c38afc46565
2690638Zunveyl 5 MG Delayed Release Oral TabletSYaf47bf67-1f07-4650-8064-24c38afc46565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84054-005-148405400051414 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-14) 2024-08-09YesNoCurrent
84054-005-608405400056060 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-60) 2024-08-09NoNoCurrent