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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	27241-039		I	Inactivated by FDA		2026-08-17
excluded package	package	27241-039	27241-039-11	I	Inactivated by FDA		2026-08-17

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205186-001	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB		2017-08-29
A205186-002	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB		2017-08-29

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205186-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205186-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2017-08-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205186-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205186-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205186-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205186-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205186-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205186-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205186-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205186-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205186-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205186-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205186-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205186-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205186-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205186-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205186-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205186-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205186-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205186-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205186-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205186-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205186-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205186-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205186-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205186-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205186-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205186-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205186-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205186-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205186-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205186-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205186-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205186-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205186-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205186-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205186-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205186-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205186-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205186-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205186-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205186-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca727413-0b46-77de-6659-26418dfe7a5a	Product name	6	20230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
27241-039-11	2026-01-29	C162847	48780-1	49896155-a1ec-586f-e063-e6dba90add90	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
27241-039-11	eletriptan hydrobromide	1 in 1 CARTON	TABLET, FILM COATED	1		9
27241-039-68	eletriptan hydrobromide	6 in 1 BLISTER PACK	TABLET, FILM COATED	6		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-039-11	EA - Each	27241-039	ea9cbea5-8d25-454b-b495-fe3a7e45ad3a	1	2017-09-11
27241-039-68	EA - Each	27241-039	1353c5f0-b80c-4d90-b329-ce2ab2a5f1c4	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-039	ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [AJANTA PHARMA USA INC.]	9	Legacy NDC, 2 package rows	20211123_a65315d7-a30a-4c1f-95a9-30226e559c3d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eletriptan HBR	ELETRIPTAN HBR	Direct_Rx	f6dc0893-b845-4f96-e053-6294a90a856f	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205186 application number: ANDA205186

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M41W832TA3	ELETRIPTAN HYDROBROMIDE	177834-92-3	ELETRIPTAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359493	eletriptan HBr 20 MG Oral Tablet	PSN	a65315d7-a30a-4c1f-95a9-30226e559c3d	9
359494	eletriptan HBr 40 MG Oral Tablet	PSN	a65315d7-a30a-4c1f-95a9-30226e559c3d	9
359493	eletriptan 20 MG Oral Tablet	SCD	a65315d7-a30a-4c1f-95a9-30226e559c3d	9
359494	eletriptan 40 MG Oral Tablet	SCD	a65315d7-a30a-4c1f-95a9-30226e559c3d	9
359493	eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral Tablet	SY	a65315d7-a30a-4c1f-95a9-30226e559c3d	9
359494	eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral Tablet	SY	a65315d7-a30a-4c1f-95a9-30226e559c3d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-039-11	27241003911	1 BLISTER PACK in 1 CARTON (27241-039-11) > 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-039-68)	1 blister pack	2017-08-29	0000-00-00	No	No	Current
27241-039-68	27241003968	6 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
eletriptan hydrobromide	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited	2021-11-22	Human Prescription Drug Label	9