FDA.reportPublic FDA data

eletriptan hydrobromide

Product NDC
27241-039
11-digit product format
272410039
Labeler code
27241
Product ID
27241-039_43c6da47-7266-4987-96a4-3d6970a390c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA205186
Marketing category
ANDA
Marketing start
2017-08-29
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca727413-0b46-77de-6659-26418dfe7a5aProduct name620230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27241-039-112026-01-29C16284748780-149896155-a1ec-586f-e063-e6dba90add90These highlights do not include all the information needed to use ELETRIPTAN HYDROBROMIDE TABLETS safely and effectively. See full prescribing information for ELETRIPTAN HYDROBROMIDE TABLETS. ELETRIPTAN HYDROBROMIDE tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-039-11eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED19
27241-039-68eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-039-11EA - Each27241-039ea9cbea5-8d25-454b-b495-fe3a7e45ad3a12017-09-11
27241-039-68EA - Each27241-0391353c5f0-b80c-4d90-b329-ce2ab2a5f1c412017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-039ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [AJANTA PHARMA USA INC.]9Legacy NDC, 2 package rows20211123_a65315d7-a30a-4c1f-95a9-30226e559c3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSNa65315d7-a30a-4c1f-95a9-30226e559c3d9
359494eletriptan HBr 40 MG Oral TabletPSNa65315d7-a30a-4c1f-95a9-30226e559c3d9
359493eletriptan 20 MG Oral TabletSCDa65315d7-a30a-4c1f-95a9-30226e559c3d9
359494eletriptan 40 MG Oral TabletSCDa65315d7-a30a-4c1f-95a9-30226e559c3d9
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSYa65315d7-a30a-4c1f-95a9-30226e559c3d9
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSYa65315d7-a30a-4c1f-95a9-30226e559c3d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-039-11272410039111 BLISTER PACK in 1 CARTON (27241-039-11) > 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-039-68) 1 blister pack2017-08-290000-00-00NoNoCurrent
27241-039-68272410039686 in 1 BLISTER PACKHistorical