FDA.reportPublic FDA data

Eletriptan Hydrobromide

Product NDC
63629-8320
11-digit product format
636298320
Labeler code
63629
Product ID
63629-8320_ac134921-c0d8-46a0-96a7-014ff1e4aa95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210708
Marketing category
ANDA
Marketing start
2018-02-16
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
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 HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM41W832TA3
Rxcui359494

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
63629-8320-1Eletriptan Hydrobromide9 in 1 BOTTLETABLET, FILM COATED91003
63629-8320-2Eletriptan Hydrobromide30 in 1 BOTTLETABLET, FILM COATED301003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8320-1EA - Each63629-8320eb85a37b-20aa-4b6e-835c-f16eb26c87f812022-05-04
63629-8320-2EA - Each63629-832090691e20-63ba-45b5-8d49-bcba1d2d293412022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8320ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003Current NDC, Legacy NDC, 2 package rows20240915_a3953ca6-3da6-4420-9eb5-a16b38372f4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359494eletriptan HBr 40 MG Oral TabletPSNa3953ca6-3da6-4420-9eb5-a16b38372f4e1003
359494eletriptan 40 MG Oral TabletSCDa3953ca6-3da6-4420-9eb5-a16b38372f4e1003
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSYa3953ca6-3da6-4420-9eb5-a16b38372f4e1003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8320-1636298320019 TABLET, FILM COATED in 1 BOTTLE (63629-8320-1) 2020-05-180000-00-00NoNoCurrent
63629-8320-26362983200230 TABLET, FILM COATED in 1 BOTTLE (63629-8320-2) 2021-12-070000-00-00NoNoCurrent