FDA.reportPublic FDA data

Eletriptan Hydrobromide

Product NDC
80425-0408
11-digit product format
804250408
Labeler code
80425
Product ID
80425-0408_1bbcb1f8-d717-a171-e063-6394a90a5d98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA210708
Marketing category
ANDA
Marketing start
2024-06-25
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
80425-0408-1Eletriptan Hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED61
80425-0408-1Eletriptan Hydrobromide1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0408-1EA - Each80425-04085d676a6a-34b4-4b5a-9997-14e3ad4ee7d612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0408ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 2 package rows20240627_1bbcb13f-d1cb-82c1-e063-6394a90a7753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359494eletriptan HBr 40 MG Oral TabletPSN1bbcb13f-d1cb-82c1-e063-6394a90a77531
359494eletriptan 40 MG Oral TabletSCD1bbcb13f-d1cb-82c1-e063-6394a90a77531
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY1bbcb13f-d1cb-82c1-e063-6394a90a77531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0408-1804250408011 BLISTER PACK in 1 CARTON (80425-0408-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-06-25NoNoHistorical