FDA.reportPublic FDA data

Eletriptan hydrobromide

Product NDC
68382-922
11-digit product format
683820922
Labeler code
68382
Product ID
68382-922_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206409
Marketing category
ANDA
Marketing start
2017-07-12
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
68382-922-06Eletriptan hydrobromide30 in 1 BOTTLETABLET, FILM COATED305
68382-922-10Eletriptan hydrobromide1000 in 1 BOTTLETABLET, FILM COATED10005
68382-922-30Eletriptan hydrobromide10 in 1 BLISTER PACKTABLET, FILM COATED105
68382-922-77Eletriptan hydrobromide10 in 1 CARTONTABLET, FILM COATED105
68382-922-86Eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED15
68382-922-86Eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-922-86EA - Each68382-922610adea0-7846-47e4-827d-81534c8375b912017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-922ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 6 package rows20230921_e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSNe0dfeb1f-f0f0-449a-81ae-2c8fdddcff105
359494eletriptan HBr 40 MG Oral TabletPSNe0dfeb1f-f0f0-449a-81ae-2c8fdddcff105
359493eletriptan 20 MG Oral TabletSCDe0dfeb1f-f0f0-449a-81ae-2c8fdddcff105
359494eletriptan 40 MG Oral TabletSCDe0dfeb1f-f0f0-449a-81ae-2c8fdddcff105
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSYe0dfeb1f-f0f0-449a-81ae-2c8fdddcff105
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSYe0dfeb1f-f0f0-449a-81ae-2c8fdddcff105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-922-066838209220630 TABLET, FILM COATED in 1 BOTTLE (68382-922-06) 2017-07-120000-00-00NoNoCurrent
68382-922-10683820922101000 TABLET, FILM COATED in 1 BOTTLE (68382-922-10) 2017-07-120000-00-00NoNoCurrent
68382-922-306838209223010 in 1 BLISTER PACKHistorical
68382-922-776838209227710 BLISTER PACK in 1 CARTON (68382-922-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-922-30) 10 blister pack2017-07-120000-00-00NoNoCurrent
68382-922-86683820922861 BLISTER PACK in 1 CARTON (68382-922-86) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2017-07-120000-00-00NoNoCurrent