FDA.reportPublic FDA data

Eletriptan HBR

Product NDC
72189-439
Requested package NDC
72189-439-06
11-digit product format
721890439
Labeler code
72189
Product ID
72189-439_2c4d8564-463e-0128-e063-6294a90a770a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan HBR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA205186
Marketing category
ANDA
Marketing start
2023-03-14
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205186-001ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29
A205186-002ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205186-001AB
A205186-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29a50c72e98297…
2026-08-01 22:54:322026-06A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205186-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205186-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eletriptan HBRELETRIPTAN HBRDirect_Rxf6dc0893-b845-4f96-e053-6294a90a856f2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205186
application number: ANDA205186
ndc (package): 72189-439-06
ndc (product): 72189-439
ndc11 (package): 72189043906

Additional Listing Data#

Finished product
Yes
Brand name base
Eletriptan HBR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELETRIPTAN HYDROBROMIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M41W832TA3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359494Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6dc0893-b845-4f96-e053-6294a90a856fAvailable on FDA.report

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
72189-439-06Eletriptan HBR6 in 1 CARTONTABLET, FILM COATED63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-439-06EA - Each72189-439bde31041-8992-4623-8344-794bb3705ca612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-439ELETRIPTAN HBR TABLET, FILM COATED [DIRECT_RX]3Current NDC, 1 package rows20250123_f6dc0893-b845-4f96-e053-6294a90a856f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359494eletriptan HBr 40 MG Oral TabletPSNf6dc0893-b845-4f96-e053-6294a90a856f3
359494eletriptan 40 MG Oral TabletSCDf6dc0893-b845-4f96-e053-6294a90a856f3
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSYf6dc0893-b845-4f96-e053-6294a90a856f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-439-06721890439066 TABLET, FILM COATED in 1 CARTON (72189-439-06) 2023-03-14NoNoCurrent