FDA.reportPublic FDA data

Eletriptan hydrobromide

Product NDC
71335-2983
11-digit product format
713352983
Labeler code
71335
Product ID
71335-2983_1d19d99c-189e-4065-97e8-78e357d62f60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206409
Marketing category
ANDA
Marketing start
2017-07-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eletriptan hydrobromide
Listing expiration
2027-12-31

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
71335-2983-1Eletriptan hydrobromide30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359494eletriptan HBr 40 MG Oral TabletPSN7924b4fa-3e3d-4777-a59f-9320c61181961
359494eletriptan 40 MG Oral TabletSCD7924b4fa-3e3d-4777-a59f-9320c61181961
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY7924b4fa-3e3d-4777-a59f-9320c61181961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2983-17133529830130 TABLET, FILM COATED in 1 BOTTLE (71335-2983-1) 2026-02-04NoNoHistorical