eletriptan hydrobromide

Product NDC
55700-756
11-digit product format
557000756
Labeler code
55700
Product ID
55700-756_057966ca-6e48-43ed-a863-941122a1282a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA205186
Marketing category
ANDA
Marketing start
2019-05-24
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
eletriptan hydrobromide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELETRIPTAN HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM41W832TA3
Rxcui359494

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
55700-756-06eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-756-06EA - Each55700-756a2f23c47-f646-4015-864a-56fa4e33112b12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-756ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]6Current NDC, Legacy NDC, 1 package rows20241220_1728c511-d1fd-4e30-85ba-f0f5d996088b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359494eletriptan HBr 40 MG Oral TabletPSN1728c511-d1fd-4e30-85ba-f0f5d996088b6
359494eletriptan 40 MG Oral TabletSCD1728c511-d1fd-4e30-85ba-f0f5d996088b6
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY1728c511-d1fd-4e30-85ba-f0f5d996088b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-756-06557000756066 TABLET, FILM COATED in 1 BLISTER PACK (55700-756-06) 2019-05-242026-06-30NoNoCurrent