FDA.reportPublic FDA data

Relpax

Product NDC
0049-2330
11-digit product format
000492330
Labeler code
0049
Product ID
0049-2330_f6f124bc-c3e3-4ab8-b081-51068ec75eb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ROERIG
Application
NDA021016
Marketing category
NDA
Marketing start
2002-12-26
Marketing end
2026-05-31
Substance
ELETRIPTAN HYDROBROMIDE
Active strength
20 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
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca727413-0b46-77de-6659-26418dfe7a5aProduct name620230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0049-2330-452024-01-30C16284748780-11030e365-6877-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use RELPAX safely and effectively. See full prescribing information for RELPAX. RELPAX® (eletriptan hydrobromide) tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-2330-45Relpax6 in 1 CARTONTABLET, FILM COATED625
0049-2330-79Relpax1 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-2330-45EA - Each0049-23301b3778b6-eae1-4bb6-b8ec-5b62c50a93c912012-07-24
0049-2330-79EA - Each0049-233025fb32a8-3e87-465d-8cd8-25f437c606e512017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ELETRIPTAN HYDROBROMIDEACTIVE INGREDIENTM41W832TA3RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
ELETRIPTANACTIVE MOIETY22QOO9B8KIRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13
TRIACETININACTIVE INGREDIENTXHX3C3X673RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-2330RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]24Current NDC, Legacy NDC, 2 package rows20250510_85745375-fcb6-4edc-b6db-a77b4a5f3e8c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-2330-45000492330456 BLISTER PACK in 1 CARTON (0049-2330-45) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2330-79) 6 blister pack2002-12-262026-05-31NoNoCurrent
0049-2330-79000492330791 in 1 BLISTER PACKHistorical