ZUNVEYL

Product NDC
84054-015
11-digit product format
840540015
Labeler code
84054
Product ID
84054-015_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
15 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218549-001ZUNVEYLBENZGALANTAMINE GLUCONATEEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26
N218549-002ZUNVEYLBENZGALANTAMINE GLUCONATEEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26
N218549-003ZUNVEYLBENZGALANTAMINE GLUCONATEEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218549-00197639532026-12-01U-7132024-08-22
N218549-001117951762042-01-13U-713Drug substance2024-08-22
N218549-001122081672044-02-26U-713Drug product2025-02-20
N218549-001125514912045-07-23U-7132026-02-20
N218549-00297639532026-12-01U-7132024-08-22
N218549-002117951762042-01-13U-713Drug substance2024-08-22
N218549-002122081672044-02-26U-713Drug product2025-02-20
N218549-002125514912045-07-23U-7132026-02-20
N218549-00397639532026-12-01U-7132024-08-22
N218549-003117951762042-01-13U-713Drug substance2024-08-22
N218549-003122081672044-02-26U-713Drug product2025-02-20
N218549-003125514912045-07-23U-7132026-02-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2679d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218549-00197639532026-12-01U-7132024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-001117951762042-01-13U-713Drug substance2024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-001122081672044-02-26U-713Drug product2025-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-00297639532026-12-01U-7132024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-002117951762042-01-13U-713Drug substance2024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-002122081672044-02-26U-713Drug product2025-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-00397639532026-12-01U-7132024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-003117951762042-01-13U-713Drug substance2024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218549-003122081672044-02-26U-713Drug product2025-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-00197639532026-12-01U-7132024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-001117951762042-01-13U-713Drug substance2024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-001122081672044-02-26U-713Drug product2025-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-00297639532026-12-01U-7132024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-002117951762042-01-13U-713Drug substance2024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-002122081672044-02-26U-713Drug product2025-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-00397639532026-12-01U-7132024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-003117951762042-01-13U-713Drug substance2024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218549-003122081672044-02-26U-713Drug product2025-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N218549-00197639532026-12-01U-7132024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-001117951762042-01-13U-713Drug substance2024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-001122081672044-02-26U-713Drug product2025-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-00297639532026-12-01U-7132024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-002117951762042-01-13U-713Drug substance2024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-002122081672044-02-26U-713Drug product2025-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-00397639532026-12-01U-7132024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-003117951762042-01-13U-713Drug substance2024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218549-003122081672044-02-26U-713Drug product2025-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-00197639532026-12-01U-7132024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-001117951762042-01-13U-713Drug substance2024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-001122081762044-02-26U-713Drug product2025-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-00297639532026-12-01U-7132024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-002117951762042-01-13U-713Drug substance2024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-002122081762044-02-26U-713Drug product2025-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-00397639532026-12-01U-7132024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-003117951762042-01-13U-713Drug substance2024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218549-003122081762044-02-26U-713Drug product2025-02-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-00197639532026-12-01U-7132024-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-001117951762042-01-13U-713Drug substance2024-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-00297639532026-12-01U-7132024-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218549-002117951762042-01-13U-713Drug substance2024-08-22b8a1b40f171c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZGALANTAMINE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XOI2Q0ZF7GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2690632Internal RxNorm lookup
2690638Internal RxNorm lookup
2690640Internal RxNorm lookup
2690642Internal RxNorm lookup
2690644Internal RxNorm lookup
2690646Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
af47bf67-1f07-4650-8064-24c38afc4656Available on FDA.report

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
84054-015-60ZUNVEYL60 in 1 BOTTLETABLET, DELAYED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84054-015-60EA - Each84054-015a8fbf593-1040-4f22-ade4-bcdcfcb39e0812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84054-015ZUNVEYL (BENZGALANTAMINE) TABLET, DELAYED RELEASE [ALPHA COGNITION, INC.]4Current NDC, 1 package rows20250221_af47bf67-1f07-4650-8064-24c38afc4656.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZUNVEYLBENZGALANTAMINEAlpha Cognition, Inc.af47bf67-1f07-4650-8064-24c38afc46562026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 218549
application number: NDA218549
ndc (product): 84054-015

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
84054-015-608405400156060 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-015-60) 2024-08-09NoNoCurrent