ZUNVEYL

Product NDC
84054-015
11-digit product format
840540015
Labeler code
84054
Product ID
84054-015_7d3fb7d4-592e-44be-9391-6aac12cf25db
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 43.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-2684e616aacf4f…
2026-09-14 22:38:342026-08N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2684e616aacf4f…
2026-09-14 22:38:342026-08N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-2684e616aacf4f…
2026-08-18 06:07:402026-07N218549-001ZUNVEYLEQ 5MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2024-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-002ZUNVEYLEQ 10MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-003ZUNVEYLEQ 15MG BASETABLET, DELAYED RELEASE / ORALRLD2024-07-26caaa826d4ba7…
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…

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218549-00197639532026-12-01U-7132024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218549-001117951762042-01-13U-713Drug substance2024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218549-001122081672044-02-26U-713Drug product2025-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N218549-001125514912045-07-23U-7132026-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N218549-00297639532026-12-01U-7132024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218549-002117951762042-01-13U-713Drug substance2024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218549-002122081672044-02-26U-713Drug product2025-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N218549-002125514912045-07-23U-7132026-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N218549-00397639532026-12-01U-7132024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218549-003117951762042-01-13U-713Drug substance2024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218549-003122081672044-02-26U-713Drug product2025-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N218549-003125514912045-07-23U-7132026-02-2084e616aacf4f…
2026-08-18 06:07:402026-07N218549-00197639532026-12-01U-7132024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-001117951762042-01-13U-713Drug substance2024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-001122081672044-02-26U-713Drug product2025-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-001125514912045-07-23U-7132026-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-00297639532026-12-01U-7132024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-002117951762042-01-13U-713Drug substance2024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-002122081672044-02-26U-713Drug product2025-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-002125514912045-07-23U-7132026-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-00397639532026-12-01U-7132024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-003117951762042-01-13U-713Drug substance2024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-003122081672044-02-26U-713Drug product2025-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N218549-003125514912045-07-23U-7132026-02-20caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZGALANTAMINE15 mg/1

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

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