FDA.reportPublic FDA data

SYMBRAVO

Product NDC
81968-020
11-digit product format
819680020
Labeler code
81968
Product ID
81968-020_2d0cbcfb-3201-4bc3-84e2-b6692fc218a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam, rizatriptan
Dosage form
TABLET
Route
ORAL
Labeler
Axsome Therapeutics, Inc.
Application
NDA215431
Marketing category
NDA
Marketing start
2025-05-19
Substance
MELOXICAM; RIZATRIPTAN BENZOATE
Active strength
20; 10 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215431-001SYMBRAVOMELOXICAM; RIZATRIPTAN BENZOATE20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30

Orange Book patents#

Current patent rows page 1 of 2 · 96 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215431-001100290102036-04-11U-41332025-02-27
N215431-001100586142036-04-11Drug product2025-02-27
N215431-001101371312036-04-11U-1719Drug product2025-02-27
N215431-001101952782036-04-11U-17192025-02-27
N215431-001102653242036-04-11U-17192025-02-27
N215431-001102653992036-04-11U-45092026-05-22
N215431-001102654002036-04-11U-45092026-05-22
N215431-001103074842036-04-11U-45092026-05-22
N215431-001103633122036-04-11U-17192025-02-27
N215431-001103692242036-04-11U-41342025-02-27
N215431-001103692252036-04-11U-43562026-05-22
N215431-001104268392036-04-11U-41352025-02-27
N215431-001104564712036-04-11U-45092026-05-22
N215431-001104637362036-04-11Drug product2025-02-27
N215431-001104710142036-04-11U-17192025-02-27
N215431-001104710692036-04-11U-17192025-02-27
N215431-001105126922036-04-11U-17192025-02-27
N215431-001105126932036-04-11U-17192025-02-27
N215431-001105179502036-04-11U-17192025-02-27
N215431-001105321012036-04-11U-17192025-02-27
N215431-001105376422036-04-11U-17192025-02-27
N215431-001105616642036-04-11U-17192025-02-27
N215431-001105831442036-04-11U-17192025-02-27
N215431-001106537772036-04-11U-17192025-02-27
N215431-001106881022036-04-11U-17192025-02-27
N215431-001106881852036-04-11U-17192025-02-27
N215431-001106954292036-04-11U-17192025-02-27
N215431-001106954302036-04-11U-17192025-02-27
N215431-001107025352036-04-11U-41362025-02-27
N215431-001107026022036-04-11U-17192025-02-27
N215431-001107225832036-04-11U-17192025-02-27
N215431-001107296962036-04-11U-17192025-02-27
N215431-001107296972036-04-11U-17192025-02-27
N215431-001107297732036-04-11U-17192025-02-27
N215431-001107586172036-04-11U-17192025-02-27
N215431-001107586182036-04-11U-17192025-02-27
N215431-001107801652036-04-11U-17192025-02-27
N215431-001107801662036-04-11U-17192025-02-27
N215431-001107995882036-04-11U-17192025-02-27
N215431-001108211812036-04-11U-17192025-02-27
N215431-001108211822036-04-11U-17192025-02-27
N215431-001108940532036-04-11U-17192025-02-27
N215431-001109056932036-04-11U-17192025-02-27
N215431-001109187222036-04-11U-17192025-02-27
N215431-001109331362036-04-11U-17192025-02-27
N215431-001109331372036-04-11U-17192025-02-27
N215431-001109401532036-04-11U-17192025-02-27
N215431-001109873582036-04-11U-17192025-02-27
N215431-001110138052036-04-11U-17192025-02-27
N215431-001110138062036-04-11U-17192025-02-27
N215431-001110204832036-04-11U-17192025-02-27
N215431-001110455492036-04-11U-17192025-02-27
N215431-001111352952036-04-11U-17192025-02-27
N215431-001112073282036-04-11U-17192025-02-27
N215431-001112196262036-04-11U-17192025-02-27
N215431-001112666572036-04-11U-17192026-05-22
N215431-001112852132036-04-11U-17192025-02-27
N215431-001113313232036-04-11U-17192025-02-27
N215431-001113696842036-04-11U-17192025-02-27
N215431-001114264142036-04-11U-17192025-02-27
N215431-001114330782036-04-11U-17192026-05-22
N215431-001114330792036-04-11U-17192026-05-22
N215431-001114714642036-04-11U-17192025-02-27
N215431-001114714652036-04-11U-17192025-02-27
N215431-001115044292036-04-11U-17192025-02-27
N215431-001115109272036-04-11U-17192025-02-27
N215431-001115714282036-04-11U-17192025-02-27
N215431-001116025632036-04-11U-17192025-02-27
N215431-001116074562036-04-11U-17192025-02-27
N215431-001116177552036-04-11U-17192025-02-27
N215431-001116177562036-04-11U-17192025-02-27
N215431-001116177912036-04-11U-17192025-02-27
N215431-001116281732036-04-11U-17192025-02-27
N215431-001117124412036-04-11U-17192025-02-27
N215431-001117380852036-04-11U-17192025-02-27
N215431-001117595222036-04-11U-17192025-02-27
N215431-001118012502036-04-11U-17192025-02-27
N215431-001118063542036-04-11U-17192025-02-27
N215431-001118263702036-04-11U-17192025-02-27
N215431-001118651172036-04-11U-17192025-02-27

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215431-001NP2028-01-30

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
2026-10-15 13:18:302026-09N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30c2088c7a36db…
2026-09-14 22:38:342026-08N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-3084e616aacf4f…
2026-08-18 06:07:402026-07N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215431-001SYMBRAVO20MG;EQ 10MG BASETABLET / ORALRLD, RS2025-01-30a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 18 · 683 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N215431-001100290102036-04-11U-41332025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001100586142036-04-11Drug product2025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001101371312036-04-11U-1719Drug product2025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001101952782036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001102653242036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001102653992036-04-11U-45092026-05-22c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001102654002036-04-11U-45092026-05-22c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001103074842036-04-11U-45092026-05-22c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001103633122036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001103692242036-04-11U-41342025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001103692252036-04-11U-43562026-05-22c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001104268392036-04-11U-41352025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001104564712036-04-11U-45092026-05-22c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001104637362036-04-11Drug product2025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001104710142036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001104710692036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105126922036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105126932036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105179502036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105321012036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105376422036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105616642036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001105831442036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001106537772036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001106881022036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001106881852036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001106954292036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001106954302036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107025352036-04-11U-41362025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107026022036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107225832036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107296962036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107296972036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107297732036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107586172036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107586182036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107801652036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107801662036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001107995882036-04-11U-17192025-02-27c2088c7a36db…
2026-10-15 13:18:302026-09N215431-001108211812036-04-11U-17192025-02-27c2088c7a36db…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N215431-001NP2028-01-30c2088c7a36db…
2026-09-14 22:38:342026-08N215431-001NP2028-01-3084e616aacf4f…
2026-08-18 06:07:402026-07N215431-001NP2028-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215431-001NP2028-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215431-001NP2028-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N215431-001NP2028-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215431-001NP2028-01-30fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215431-001NP2028-01-30a50c72e98297…

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
SYMBRAVO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM20 mg/1
RIZATRIPTAN BENZOATE10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
8b537454-32b8-7e64-1395-258682782d07Product name520170424
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81968-020-02SYMBRAVO1 in 1 CARTONTABLET15
81968-020-02SYMBRAVO2 in 1 BOTTLETABLET25
81968-020-03SYMBRAVO3 in 1 BOTTLETABLET35
81968-020-03SYMBRAVO1 in 1 CARTONTABLET15
81968-020-09SYMBRAVO9 in 1 BOTTLETABLET95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81968-020-09EA - Each81968-020f539d324-98bb-4e05-af0b-ec04970b98b112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81968-020SYMBRAVO (MELOXICAM, RIZATRIPTAN) TABLET [AXSOME THERAPEUTICS, INC.]3Current NDC, 5 package rows20250520_dcf1ecd1-08a0-8e47-e053-2a95a90abdc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711789meloxicam 20 MG / rizatriptan 10 MG Oral TabletPSNdcf1ecd1-08a0-8e47-e053-2a95a90abdc75
2711795SYMBRAVO 20 MG / 10 MG Oral TabletPSNdcf1ecd1-08a0-8e47-e053-2a95a90abdc75
2711795meloxicam 20 MG / rizatriptan 10 MG Oral Tablet [Symbravo]SBDdcf1ecd1-08a0-8e47-e053-2a95a90abdc75
2711789meloxicam 20 MG / rizatriptan 10 MG Oral TabletSCDdcf1ecd1-08a0-8e47-e053-2a95a90abdc75
2711789meloxicam 20 MG / rizatriptan 10 MG (as rizatriptan benzoate 14.5 MG) Oral TabletSYdcf1ecd1-08a0-8e47-e053-2a95a90abdc75
2711795Symbravo (meloxicam 20 MG / rizatriptan 10 MG) Oral TabletSYdcf1ecd1-08a0-8e47-e053-2a95a90abdc75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81968-020-02819680020021 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE1 bottle2025-11-21YesNoCurrent
81968-020-03819680020031 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE1 bottle2025-05-19YesNoCurrent
81968-020-09819680020099 TABLET in 1 BOTTLE (81968-020-09) 9 tablet2025-05-19NoNoCurrent