FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
82619-112
11-digit product format
826190112
Labeler code
82619
Product ID
82619-112_40b947bf-a78e-6681-e063-6294a90ad145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Application
ANDA202047
Marketing category
ANDA
Marketing start
2012-12-31
Substance
RIZATRIPTAN BENZOATE
Active strength
10 mg/1
Pharmacologic classes
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
RIZATRIPTAN BENZOATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312840, 314209

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
8b537454-32b8-7e64-1395-258682782d07Product name520170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82619-112-01RIZATRIPTAN BENZOATE30 in 1 BOTTLETABLET303
82619-112-02RIZATRIPTAN BENZOATE1000 in 1 BOTTLETABLET10003
82619-112-04RIZATRIPTAN BENZOATE2 in 1 CARTONTABLET23
82619-112-04RIZATRIPTAN BENZOATE6 in 1 BLISTER PACKTABLET63
82619-112-05RIZATRIPTAN BENZOATE6 in 1 BLISTER PACKTABLET63
82619-112-05RIZATRIPTAN BENZOATE3 in 1 CARTONTABLET33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82619-112-04EA - Each82619-11216fd0e88-d9fa-4ffc-b0f9-a0c2604ec70812023-10-16
82619-112-05EA - Each82619-1124c735f35-4812-49b8-bf84-41ab4bcac9ef12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82619-112RIZATRIPTAN BENZOATE TABLET [CREEKWOOD PHARMACEUTICALS LLC]2Current NDC, 6 package rows20241016_b517896b-167e-47d5-801d-7458f80e8ee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNb517896b-167e-47d5-801d-7458f80e8ee23
312840rizatriptan benzoate 5 MG Oral TabletPSNb517896b-167e-47d5-801d-7458f80e8ee23
314209rizatriptan 10 MG Oral TabletSCDb517896b-167e-47d5-801d-7458f80e8ee23
312840rizatriptan 5 MG Oral TabletSCDb517896b-167e-47d5-801d-7458f80e8ee23
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYb517896b-167e-47d5-801d-7458f80e8ee23
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSYb517896b-167e-47d5-801d-7458f80e8ee23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-112-018261901120130 TABLET in 1 BOTTLE (82619-112-01) 30 tablet2023-09-15NoNoHistorical
82619-112-02826190112021000 TABLET in 1 BOTTLE (82619-112-02) 1000 tablet2023-09-15NoNoHistorical
82619-112-04826190112042 BLISTER PACK in 1 CARTON (82619-112-04) / 6 TABLET in 1 BLISTER PACK2 blister pack2023-09-15NoNoHistorical
82619-112-05826190112053 BLISTER PACK in 1 CARTON (82619-112-05) / 6 TABLET in 1 BLISTER PACK3 blister pack2023-09-15NoNoHistorical