FDA.reportPublic FDA data

Eletriptan hydrobromide

Product NDC
70771-1108
11-digit product format
707711108
Labeler code
70771
Product ID
70771-1108_b0459347-b3de-466e-b386-85665dd294c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
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
70771-1108-2Eletriptan hydrobromide10 in 1 BLISTER PACKTABLET, FILM COATED107
70771-1108-3Eletriptan hydrobromide30 in 1 BOTTLETABLET, FILM COATED307
70771-1108-4Eletriptan hydrobromide10 in 1 CARTONTABLET, FILM COATED107
70771-1108-5Eletriptan hydrobromide500 in 1 BOTTLETABLET, FILM COATED5007
70771-1108-6Eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED67
70771-1108-6Eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1108ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 6 package rows20241201_481ae7d4-9e57-424a-9d07-2920954b6ddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN481ae7d4-9e57-424a-9d07-2920954b6ddc7
359494eletriptan HBr 40 MG Oral TabletPSN481ae7d4-9e57-424a-9d07-2920954b6ddc7
359493eletriptan 20 MG Oral TabletSCD481ae7d4-9e57-424a-9d07-2920954b6ddc7
359494eletriptan 40 MG Oral TabletSCD481ae7d4-9e57-424a-9d07-2920954b6ddc7
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY481ae7d4-9e57-424a-9d07-2920954b6ddc7
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY481ae7d4-9e57-424a-9d07-2920954b6ddc7
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1108-27077111080210 in 1 BLISTER PACKHistorical
70771-1108-37077111080330 TABLET, FILM COATED in 1 BOTTLE (70771-1108-3) 2017-07-120000-00-00NoNoCurrent
70771-1108-47077111080410 BLISTER PACK in 1 CARTON (70771-1108-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1108-2) 10 blister pack2017-07-120000-00-00NoNoCurrent
70771-1108-570771110805500 TABLET, FILM COATED in 1 BOTTLE (70771-1108-5) 2017-07-120000-00-00NoNoCurrent
70771-1108-6707711108061 BLISTER PACK in 1 CARTON (70771-1108-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2017-07-120000-00-00NoNoCurrent