FDA.reportPublic FDA data

AUVELITY

Product NDC
81968-045
11-digit product format
819680045
Labeler code
81968
Product ID
81968-045_948d108e-f3a6-4e83-a4f2-ff8edf184e1b
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
DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE
Active strength
45; 105 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215430-001AUVELITYBUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18
N215430-002AUVELITYBUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE105MG;30MGTABLET, EXTENDED RELEASE / ORALRLD2026-04-30

Orange Book patents#

Current patent rows page 1 of 4 · 268 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215430-00185693282032-07-18U-3419Drug product2022-09-16
N215430-00185693282032-07-18U-4516Drug product2022-09-16
N215430-001100585182034-11-05U-34192022-09-16
N215430-001100585182034-11-05U-45222022-09-16
N215430-001100648572034-11-05U-34192022-09-16
N215430-001100648572034-11-05U-45172022-09-16
N215430-001100807272034-11-05U-34192022-09-16
N215430-001100807272034-11-05U-45202022-09-16
N215430-001100925602034-11-05U-34192022-09-16
N215430-001100925602034-11-05U-45172022-09-16
N215430-001100925612034-11-05U-34192022-09-16
N215430-001100925612034-11-05U-45172022-09-16
N215430-001101053272034-11-05U-34192022-09-16
N215430-001101053612034-11-05U-34192022-09-16
N215430-001101053612034-11-05U-45222022-09-16
N215430-001102518792034-11-05U-34192022-09-16
N215430-001102518792034-11-05U-45172022-09-16
N215430-001104636342034-11-05U-34192022-09-16
N215430-001104636342034-11-05U-45172022-09-16
N215430-001105126432034-11-05U-34192022-09-16
N215430-001105126432034-11-05U-45172022-09-16
N215430-001105488572034-11-05U-34192022-09-16
N215430-001105961672034-11-05U-34192022-09-16
N215430-001105961672034-11-05U-45172022-09-16
N215430-001107728502034-11-05U-34192022-09-16
N215430-001107800662034-11-05U-34192022-09-16
N215430-001107800662034-11-05U-45172022-09-16
N215430-001107864692034-11-05U-34192022-09-16
N215430-001107864962034-11-05U-34192022-09-16
N215430-001107864962034-11-05U-45172022-09-16
N215430-001107994972034-11-05U-34192022-09-16
N215430-001108067102034-11-05U-34192022-09-16
N215430-001108067102034-11-05U-45172022-09-16
N215430-001108642092034-11-05U-34192022-09-16
N215430-001108746632034-11-05U-34192022-09-16
N215430-001108746642034-11-05U-34192022-09-16
N215430-001108746652034-11-05U-34192022-09-16
N215430-001108816242034-11-05U-34192022-09-16
N215430-001108816242034-11-05U-45172022-09-16
N215430-001108816572034-11-05U-34192022-09-16
N215430-001108940462034-11-05U-34192022-09-16
N215430-001108940472034-11-05U-34192022-09-16
N215430-001108984532034-11-05U-34192022-09-16
N215430-001109330342034-11-05U-34192022-09-16
N215430-001109459732034-11-05U-34192022-09-16
N215430-001109669412034-11-05U-34192022-09-16
N215430-001109669412034-11-05U-45172022-09-16
N215430-001109669742034-11-05U-34192022-09-16
N215430-001110071892034-11-05U-45162026-05-29
N215430-001110203892034-11-05U-34192022-09-16
N215430-001110586482034-11-05U-34192022-09-16
N215430-001110652482034-11-05U-34192025-11-20
N215430-001110652482034-11-05U-45172025-11-20
N215430-001110903002034-11-05U-34192022-09-16
N215430-001110969372034-11-05U-34192022-09-16
N215430-001111233432034-11-05U-34192022-09-16
N215430-001111233442034-11-05U-34192025-11-20
N215430-001111233442034-11-05U-45172025-11-20
N215430-001111298262034-11-05U-34192022-09-16
N215430-001111413882034-11-05U-34192022-09-16
N215430-001111414162034-11-05U-34192022-09-16
N215430-001111478082034-11-05U-34192022-09-16
N215430-001111855152034-11-05U-34192022-09-16
N215430-001111917392034-11-05U-3419Drug product2022-09-16
N215430-001111917392034-11-05U-4516Drug product2022-09-16
N215430-001111978392034-11-05U-3419Drug product2022-09-16
N215430-001111978392034-11-05U-4516Drug product2022-09-16
N215430-001112072812034-11-05U-34192022-09-16
N215430-001112072812034-11-05U-45372022-09-16
N215430-001112135212034-11-05U-34192022-09-16
N215430-001112296402034-11-05U-34192022-09-16
N215430-001112349462034-11-05U-34192022-09-16
N215430-001112349462034-11-05U-45262022-09-16
N215430-001112534912034-11-05U-34192022-09-16
N215430-001112534922034-11-05U-34192022-09-16
N215430-001112534922034-11-05U-45262022-09-16
N215430-001112731332034-11-05U-34192022-09-16
N215430-001112731332034-11-05U-45262022-09-16
N215430-001112731342034-11-05U-34192022-09-16
N215430-001112731342034-11-05U-45172022-09-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215430-001I-9132029-04-30
N215430-002I-9132029-04-30

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
2026-09-14 22:38:342026-08N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-1884e616aacf4f…
2026-09-14 22:38:342026-08N215430-002AUVELITY105MG;30MGTABLET, EXTENDED RELEASE / ORALRLD2026-04-3084e616aacf4f…
2026-08-18 06:07:402026-07N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07N215430-002AUVELITY105MG;30MGTABLET, EXTENDED RELEASE / ORALRLD2026-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18e64feba35796…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215430-001AUVELITY105MG;45MGTABLET, EXTENDED RELEASE / ORALRLD, RS2022-08-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215430-002AUVELITY105MG;30MGTABLET, EXTENDED RELEASE / ORALRLD2026-04-30a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 92 · 3,655 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N215430-00185693282032-07-18U-3419Drug product2022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-00185693282032-07-18U-4516Drug product2022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100585182034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100585182034-11-05U-45222022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100648572034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100648572034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100807272034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100807272034-11-05U-45202022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100925602034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100925602034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100925612034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001100925612034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001101053272034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001101053612034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001101053612034-11-05U-45222022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001102518792034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001102518792034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001104636342034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001104636342034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001105126432034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001105126432034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001105488572034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001105961672034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001105961672034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107728502034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107800662034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107800662034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107864692034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107864962034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107864962034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001107994972034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108067102034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108067102034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108642092034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108746632034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108746642034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108746652034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108816242034-11-05U-34192022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108816242034-11-05U-45172022-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N215430-001108816572034-11-05U-34192022-09-1684e616aacf4f…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N215430-001I-9132029-04-3084e616aacf4f…
2026-09-14 22:38:342026-08N215430-002I-9132029-04-3084e616aacf4f…
2026-08-18 06:07:402026-07N215430-001I-9132029-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N215430-002I-9132029-04-30caaa826d4ba7…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215430-001NP2025-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215430-001NP2025-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215430-001NP2025-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215430-001NP2025-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215430-001NP2025-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215430-001NP2025-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215430-001NP2025-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215430-001NP2025-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215430-001NP2025-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215430-001NP2025-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215430-001NP2025-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215430-001NP2025-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215430-001NP2025-08-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215430-001NP2025-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215430-001NP2025-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215430-001NP2025-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215430-001NP2025-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215430-001NP2025-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215430-001NP2025-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N215430-001NP2025-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N215430-001NP2025-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N215430-001NP2025-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N215430-001NP2025-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N215430-001NP2025-08-18f41ea6bd6efb…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215430-001I-9132029-04-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215430-002I-9132029-04-30a50c72e98297…

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
AUVELITY
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2611260Internal RxNorm lookup
2611266Internal RxNorm lookup
2741701Internal RxNorm lookup
2741703Internal RxNorm lookup
2744512Internal RxNorm lookup
2744513Internal RxNorm lookup
2744514Internal RxNorm lookup
2744515Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dcefda7c-9a68-278e-e053-2995a90aec79Available on FDA.report

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

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
AUVELITYDEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDEAxsome Therapeutics, Inc.dcefda7c-9a68-278e-e053-2995a90aec792026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215430
application number: NDA215430
ndc (product): 81968-045

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