ELETRIPTAN HYDROBROMIDE TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:18:23

Label at a glance#

ProductEletriptan hydrobromide
Active ingredientELETRIPTAN HYDROBROMIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eletriptan hydrobromide Tablets, 20 mg

NDC 70771-1107-3

Rx only

30 Tablets

ELETRIPTAN HYDROBROMIDE TABLET
ELETRIPTAN HYDROBROMIDE TABLET

Eletriptan hydrobromide Tablets, 40 mg

NDC 70771-1108-3

Rx only

30 Tablets

Eletriptan hydrobromide tablet
Eletriptan hydrobromide tablet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359493eletriptan HBr 20 MG Oral TabletPSN7
359494eletriptan HBr 40 MG Oral TabletPSN7
359493eletriptan 20 MG Oral TabletSCD7
359494eletriptan 40 MG Oral TabletSCD7
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY7
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ELETRIPTAN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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
70771-1107-0Eletriptan hydrobromide1000 in 1 BOTTLETABLET, FILM COATED10007
70771-1107-2Eletriptan hydrobromide10 in 1 BLISTER PACKTABLET, FILM COATED107
70771-1107-3Eletriptan hydrobromide30 in 1 BOTTLETABLET, FILM COATED307
70771-1107-4Eletriptan hydrobromide10 in 1 CARTONTABLET, FILM COATED107
70771-1107-6Eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED17
70771-1107-6Eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED67
70771-1108-2Eletriptan hydrobromide10 in 1 BLISTER PACKTABLET, FILM COATED107
70771-1108-3Eletriptan hydrobromide30 in 1 BOTTLETABLET, FILM COATED307
70771-1108-4Eletriptan hydrobromide10 in 1 CARTONTABLET, FILM COATED107
70771-1108-5Eletriptan hydrobromide500 in 1 BOTTLETABLET, FILM COATED5007
70771-1108-6Eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED67
70771-1108-6Eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1107ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 6 package rows20241201_481ae7d4-9e57-424a-9d07-2920954b6ddc.zip
70771-1108ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 6 package rows20241201_481ae7d4-9e57-424a-9d07-2920954b6ddc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206409-001ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16
A206409-002ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206409-001AB
A206409-002AB

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16c2088c7a36db…
2026-10-15 13:18:302026-09A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16c2088c7a36db…
2026-09-14 22:38:342026-08A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-1684e616aacf4f…
2026-08-18 06:07:402026-07A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206409-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-06-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206409-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-06-164b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A206409-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206409-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A206409-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206409-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A206409-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206409-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206409-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206409-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206409-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206409-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206409-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206409-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206409-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206409-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206409-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206409-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206409-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206409-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206409-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206409-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206409-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206409-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206409-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206409-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206409-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206409-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206409-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206409-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206409-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206409-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206409-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206409-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206409-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206409-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206409-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206409-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206409-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206409-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206409-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206409-002AB14b0b4de00fa7…

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 HYDROBROMIDEZydus Lifesciences Limited481ae7d4-9e57-424a-9d07-2920954b6ddc2024-11-28Exact identifier
ndc (package): 70771-1107-6
ndc (package): 70771-1107-2
ndc (package): 70771-1107-4
ndc (package): 70771-1108-2
ndc (package): 70771-1107-3
ndc (package): 70771-1108-5
ndc (package): 70771-1108-3
ndc (package): 70771-1108-6
ndc (package): 70771-1107-0
ndc (package): 70771-1108-4
ndc (product): 70771-1107
ndc (product): 70771-1108
ndc11 (package): 70771110702
ndc11 (package): 70771110806
ndc11 (package): 70771110700
ndc11 (package): 70771110706
ndc11 (package): 70771110802
ndc11 (package): 70771110804
ndc11 (package): 70771110703
ndc11 (package): 70771110805
ndc11 (package): 70771110704
ndc11 (package): 70771110803
spl id: b0459347-b3de-466e-b386-85665dd294c9
spl set id: 481ae7d4-9e57-424a-9d07-2920954b6ddc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.