FDA.reportPublic FDA data

SYMBRAVO

Product NDC
81968-020
11-digit product format
819680020
Labeler code
81968
Product ID
81968-020_b625951b-f029-470d-8d35-f5b6a92a06bb
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
2026-12-31
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 · 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
2026-09-14 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 15 · 587 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N215431-001100290102036-04-11U-41332025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001100586142036-04-11Drug product2025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001101371312036-04-11U-1719Drug product2025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001101952782036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001102653242036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001102653992036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001102654002036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103074842036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103633122036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103692242036-04-11U-41342025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001103692252036-04-11U-43562026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104268392036-04-11U-41352025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104564712036-04-11U-45092026-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104637362036-04-11Drug product2025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104710142036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001104710692036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105126922036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105126932036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105179502036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105321012036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105376422036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105616642036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001105831442036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106537772036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106881022036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106881852036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106954292036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001106954302036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107025352036-04-11U-41362025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107026022036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107225832036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107296962036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107296972036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107297732036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107586172036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107586182036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107801652036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107801662036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001107995882036-04-11U-17192025-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N215431-001108211812036-04-11U-17192025-02-2784e616aacf4f…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
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
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VG2QF83CGLInternal UNII lookup
WR978S7QHHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2711789Internal RxNorm lookup
2711795Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dcf1ecd1-08a0-8e47-e053-2a95a90abdc7Available on FDA.report

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

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
SYMBRAVOMELOXICAM, RIZATRIPTANAxsome Therapeutics, Inc.dcf1ecd1-08a0-8e47-e053-2a95a90abdc72025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215431
application number: NDA215431
ndc (product): 81968-020

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