Eletriptan Hydrobromide

Product NDC
24689-167
11-digit product format
246890167
Labeler code
24689
Product ID
24689-167_bf7e1524-0147-40cf-bd40-5ae994d551a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apnar Pharma LP
Application
ANDA215467
Marketing category
ANDA
Marketing start
2026-05-13
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
2027-12-31
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
A215467-001ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13
A215467-002ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215467-001AB
A215467-002AB

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.

Product history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-138072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-136a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-131c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-139b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215467-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2022-07-13a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215467-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2022-07-13a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215467-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215467-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215467-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215467-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215467-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215467-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215467-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215467-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215467-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215467-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215467-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215467-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215467-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215467-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215467-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215467-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215467-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215467-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215467-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215467-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215467-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215467-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215467-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215467-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215467-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215467-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215467-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215467-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215467-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215467-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215467-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215467-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215467-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215467-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215467-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215467-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215467-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215467-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215467-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215467-002AB1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
Eletriptan Hydrobromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELETRIPTAN HYDROBROMIDE20 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359493Internal RxNorm lookup
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
49686c51-bbd9-45f0-92b1-8ffa81612e35Available 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
24689-167-01Eletriptan Hydrobromide100 in 1 BOTTLETABLET, FILM COATED1002

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eletriptan HydrobromideELETRIPTAN HYDROBROMIDEApnar Pharma LP49686c51-bbd9-45f0-92b1-8ffa81612e352026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215467
application number: ANDA215467
ndc (product): 24689-167

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN49686c51-bbd9-45f0-92b1-8ffa81612e352
359494eletriptan HBr 40 MG Oral TabletPSN49686c51-bbd9-45f0-92b1-8ffa81612e352
359493eletriptan 20 MG Oral TabletSCD49686c51-bbd9-45f0-92b1-8ffa81612e352
359494eletriptan 40 MG Oral TabletSCD49686c51-bbd9-45f0-92b1-8ffa81612e352
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY49686c51-bbd9-45f0-92b1-8ffa81612e352
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY49686c51-bbd9-45f0-92b1-8ffa81612e352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24689-167-0124689016701100 TABLET, FILM COATED in 1 BOTTLE (24689-167-01) 2026-05-13NoNoCurrent