FDA.reportPublic FDA data

Eletriptan Hydrobromide

Product NDC
0378-4288
11-digit product format
003784288
Labeler code
0378
Product ID
0378-4288_cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA205152
Marketing category
ANDA
Marketing start
2017-08-15
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
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
0378-4288-08Eletriptan Hydrobromide2 in 1 CARTONTABLET, FILM COATED25
0378-4288-32Eletriptan Hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED65
0378-4288-85Eletriptan Hydrobromide1 in 1 CARTONTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4288-08EA - Each0378-4288b7cdba26-7df1-4b3f-a735-ea6e7456b45f12017-09-11
0378-4288-32EA - Each0378-428860613bd2-182f-4200-ac08-fe3da8b17cae12019-02-13
0378-4288-85EA - Each0378-42884c779f1d-e842-4806-8604-0eba090b5c8412017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4288ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20200618_20276f5c-f2d6-469f-9a1b-aa254a1db21c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN20276f5c-f2d6-469f-9a1b-aa254a1db21c5
359494eletriptan HBr 40 MG Oral TabletPSN20276f5c-f2d6-469f-9a1b-aa254a1db21c5
359493eletriptan 20 MG Oral TabletSCD20276f5c-f2d6-469f-9a1b-aa254a1db21c5
359494eletriptan 40 MG Oral TabletSCD20276f5c-f2d6-469f-9a1b-aa254a1db21c5
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY20276f5c-f2d6-469f-9a1b-aa254a1db21c5
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY20276f5c-f2d6-469f-9a1b-aa254a1db21c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4288-08003784288082 BLISTER PACK in 1 CARTON (0378-4288-08) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32) 2 blister pack2017-08-160000-00-00NoNoCurrent
0378-4288-32003784288326 in 1 BLISTER PACKHistorical
0378-4288-85003784288851 BLISTER PACK in 1 CARTON (0378-4288-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32) 1 blister pack2017-08-150000-00-00NoNoCurrent