FDA.reportPublic FDA data

Relpax

Product NDC
0049-2340
11-digit product format
000492340
Labeler code
0049
Product ID
0049-2340_60fa2e8b-4d0d-4546-a087-3f0efb3e7560
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
0000-00-00
Substance
ELETRIPTAN HYDROBROMIDE
Active strength
40 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
2022-12-31
Current FDA listing
Historical FDA.report record

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
0049-2340-052024-01-30C16284748780-11030e365-6877-111a-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
0049-2340-452024-01-30C16284748780-11030e365-6877-111a-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
0049-2340-05Relpax12 in 1 CARTONTABLET, FILM COATED1225
0049-2340-45Relpax6 in 1 CARTONTABLET, FILM COATED625
0049-2340-79Relpax1 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-2340-05EA - Each0049-23408e19521a-06b4-449a-96e1-63baa1b02fb412013-02-13
0049-2340-45EA - Each0049-234065680d40-b683-447c-86a3-ae88a6273e6112012-07-24
0049-2340-79EA - Each0049-23409fc635b3-42ab-4654-b3df-2d78299140ed12016-07-19

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
eletriptan hydrobromideACTIVE INGREDIENTM41W832TA3RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
eletriptan hydrobromideACTIVE INGREDIENTM41W832TA3RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
eletriptan hydrobromideACTIVE INGREDIENTM41W832TA3RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
eletriptanACTIVE MOIETY22QOO9B8KIRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
eletriptanACTIVE MOIETY22QOO9B8KIRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
eletriptanACTIVE MOIETY22QOO9B8KIRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WORELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WORELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1
triacetinINACTIVE INGREDIENTXHX3C3X673RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
triacetinINACTIVE INGREDIENTXHX3C3X673RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-2340RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG]24Legacy NDC, 3 package rows20250510_85745375-fcb6-4edc-b6db-a77b4a5f3e8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359494eletriptan HBr 40 MG Oral TabletPSN523b947a-4e92-42ff-886c-4317af8d7b561
359494eletriptan HBr 40 MG Oral TabletPSN6bb510c8-2ae2-4159-b4c6-0aec5e64b4c91
359494eletriptan HBr 40 MG Oral TabletPSN62c8e43a-402c-4f71-8ba4-3def66a341741
404444RELPAX 40 MG Oral TabletPSN6bb510c8-2ae2-4159-b4c6-0aec5e64b4c91
404444RELPAX 40 MG Oral TabletPSN523b947a-4e92-42ff-886c-4317af8d7b561
404444RELPAX 40 MG Oral TabletPSN62c8e43a-402c-4f71-8ba4-3def66a341741
404444eletriptan 40 MG Oral Tablet [Relpax]SBD62c8e43a-402c-4f71-8ba4-3def66a341741
404444eletriptan 40 MG Oral Tablet [Relpax]SBD6bb510c8-2ae2-4159-b4c6-0aec5e64b4c91
404444eletriptan 40 MG Oral Tablet [Relpax]SBD523b947a-4e92-42ff-886c-4317af8d7b561
359494eletriptan 40 MG Oral TabletSCD62c8e43a-402c-4f71-8ba4-3def66a341741
359494eletriptan 40 MG Oral TabletSCD6bb510c8-2ae2-4159-b4c6-0aec5e64b4c91
359494eletriptan 40 MG Oral TabletSCD523b947a-4e92-42ff-886c-4317af8d7b561
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY523b947a-4e92-42ff-886c-4317af8d7b561
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY62c8e43a-402c-4f71-8ba4-3def66a341741
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY6bb510c8-2ae2-4159-b4c6-0aec5e64b4c91
404444Relpax (as eletriptan hydrobromide) 40 MG Oral TabletSY62c8e43a-402c-4f71-8ba4-3def66a341741
404444Relpax (as eletriptan hydrobromide) 40 MG Oral TabletSY6bb510c8-2ae2-4159-b4c6-0aec5e64b4c91
404444Relpax (as eletriptan hydrobromide) 40 MG Oral TabletSY523b947a-4e92-42ff-886c-4317af8d7b561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-2340-050004923400512 BLISTER PACK in 1 CARTON (0049-2340-05) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2340-79) 12 blister pack2002-12-260000-00-00NoNoCurrent
0049-2340-45000492340456 BLISTER PACK in 1 CARTON (0049-2340-45) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2340-79) 6 blister pack2002-12-260000-00-00NoNoCurrent
0049-2340-79000492340791 in 1 BLISTER PACKHistorical