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

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 Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL, WR978S7QHH
Rxcui2711789, 2711795

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