FDA.reportPublic FDA data

Eletriptan Hydrobromide

Product NDC
0093-8310
11-digit product format
000938310
Labeler code
0093
Product ID
0093-8310_fe826d95-af0c-490d-8a5d-02218c836ff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA202040
Marketing category
ANDA
Marketing start
2017-07-21
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
0093-8310-18Eletriptan Hydrobromide6 in 1 CARTONTABLET, FILM COATED611
0093-8310-19Eletriptan Hydrobromide1 in 1 BLISTER PACKTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8310-18EA - Each0093-8310ba1a94db-da6e-454f-8305-88ba9e13116412017-08-11
0093-8310-19EA - Each0093-8310a17d2605-a01c-48d2-855d-d06eb478cc9a12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8310ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 2 package rows20250209_62dc12ce-4f19-41c6-9593-3cae29f04af1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN62dc12ce-4f19-41c6-9593-3cae29f04af111
359494eletriptan HBr 40 MG Oral TabletPSN62dc12ce-4f19-41c6-9593-3cae29f04af111
359493eletriptan 20 MG Oral TabletSCD62dc12ce-4f19-41c6-9593-3cae29f04af111
359494eletriptan 40 MG Oral TabletSCD62dc12ce-4f19-41c6-9593-3cae29f04af111
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY62dc12ce-4f19-41c6-9593-3cae29f04af111
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY62dc12ce-4f19-41c6-9593-3cae29f04af111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8310-18000938310186 BLISTER PACK in 1 CARTON (0093-8310-18) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-8310-19) 6 blister pack2017-07-210000-00-00NoNoCurrent
0093-8310-19000938310191 in 1 BLISTER PACKHistorical