FDA.reportPublic FDA data

AUVELITY

Product NDC
81968-045
11-digit product format
819680045
Labeler code
81968
Product ID
81968-045_73a644ad-38d5-49a7-9e96-187d20dffbd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextromethorphan hydrobromide, bupropion hydrochloride
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Axsome Therapeutics, Inc.
Application
NDA215430
Marketing category
NDA
Marketing start
2022-08-18
Substance
BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
105; 45 mg/1; mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE105 mg/1
DEXTROMETHORPHAN HYDROBROMIDE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, ZG7E5POY8O
Rxcui2611260, 2611266, 2741701, 2741703, 2744512, 2744513, 2744514, 2744515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81968-045-14AUVELITY14 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL1414
81968-045-14AUVELITY1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL114
81968-045-30AUVELITY30 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL3014
81968-045-31AUVELITY30 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL3014
81968-045-31AUVELITY1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL114
81968-045-60AUVELITY60 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81968-045-30EA - Each81968-045af3ac6cf-9475-4b80-9df2-c8a2ab1c54ec12022-10-06
81968-045-60EA - Each81968-04587c5d1fc-5461-4779-9952-4addedc7925e12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81968-045AUVELITY (DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [AXSOME THERAPEUTICS, INC.]8Current NDC, Legacy NDC, 6 package rows20240920_dcefda7c-9a68-278e-e053-2995a90aec79.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81968-045-14819680045141 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-09-18YesNoCurrent
81968-045-308196800453030 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) 2022-08-180000-00-00NoNoCurrent
81968-045-31819680045311 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-05-102027-03-28YesNoHistorical
81968-045-608196800456060 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) 2024-06-28NoNoCurrent