eletriptan hydrobromide

Product NDC
55700-756
Requested package NDC
55700-756-06
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-75655700-756-06DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205186-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2017-08-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205186-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2017-08-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205186-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205186-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205186-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205186-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205186-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205186-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205186-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205186-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205186-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205186-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205186-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205186-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205186-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205186-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205186-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205186-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205186-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205186-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205186-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205186-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205186-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205186-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205186-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205186-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205186-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205186-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205186-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205186-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205186-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205186-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205186-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205186-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205186-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205186-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205186-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205186-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205186-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205186-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205186-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205186-002AB1bb7c543d1eb4…

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

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 HBRELETRIPTAN HBRDirect_Rxf6dc0893-b845-4f96-e053-6294a90a856f2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205186
application number: ANDA205186

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