FDA.reportPublic FDA data

Eletriptan hydrobromide

Product NDC
31722-444
11-digit product format
317220444
Labeler code
31722
Product ID
31722-444_3d920aff-46bc-82ae-e063-6294a90a4222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219143
Marketing category
ANDA
Marketing start
2025-07-07
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
31722-444-31Eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED11
31722-444-32Eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED61
31722-444-33Eletriptan hydrobromide2 in 1 CARTONTABLET, FILM COATED21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-444-31EA - Each31722-444df7351bc-9850-44d5-bd1c-6f03a74981d112025-11-13
31722-444-32EA - Each31722-4448ed379a3-d8d4-45ff-9e9f-224e7167a2b112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN6d412c0d-c8bd-498d-b57c-6626fb33147a1
359494eletriptan HBr 40 MG Oral TabletPSN6d412c0d-c8bd-498d-b57c-6626fb33147a1
359493eletriptan 20 MG Oral TabletSCD6d412c0d-c8bd-498d-b57c-6626fb33147a1
359494eletriptan 40 MG Oral TabletSCD6d412c0d-c8bd-498d-b57c-6626fb33147a1
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY6d412c0d-c8bd-498d-b57c-6626fb33147a1
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY6d412c0d-c8bd-498d-b57c-6626fb33147a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-444-31317220444311 BLISTER PACK in 1 CARTON (31722-444-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32) 1 blister pack2025-07-07NoNoCurrent
31722-444-32317220444326 in 1 BLISTER PACKHistorical
31722-444-33317220444332 BLISTER PACK in 1 CARTON (31722-444-33) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32) 2 blister pack2025-07-07NoNoCurrent