FDA.reportPublic FDA data

Eletriptan Hydrobromide

Product NDC
59651-104
11-digit product format
596510104
Labeler code
59651
Product ID
59651-104_f505017a-a5d7-4f9a-a62f-06a28b30f645
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210708
Marketing category
ANDA
Marketing start
2019-01-15
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eletriptan Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELETRIPTAN HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM41W832TA3
Rxcui359493, 359494

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-104-06Eletriptan Hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED65
59651-104-69Eletriptan Hydrobromide1 in 1 CARTONTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-104-06EA - Each59651-1047513292c-d288-4e98-918c-b2ed6930ad5c12019-04-11
59651-104-69EA - Each59651-10428d6a607-92a6-4da8-a276-d76094e9dc8f12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-104ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20240604_bb5ea5df-4add-420d-88cb-6dabe116ca65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSNbb5ea5df-4add-420d-88cb-6dabe116ca655
359494eletriptan HBr 40 MG Oral TabletPSNbb5ea5df-4add-420d-88cb-6dabe116ca655
359493eletriptan 20 MG Oral TabletSCDbb5ea5df-4add-420d-88cb-6dabe116ca655
359494eletriptan 40 MG Oral TabletSCDbb5ea5df-4add-420d-88cb-6dabe116ca655
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSYbb5ea5df-4add-420d-88cb-6dabe116ca655
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSYbb5ea5df-4add-420d-88cb-6dabe116ca655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-104-06596510104066 in 1 BLISTER PACKHistorical
59651-104-69596510104691 BLISTER PACK in 1 CARTON (59651-104-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-104-06) 1 blister pack2019-01-150000-00-00NoNoCurrent