Eletriptan Hydrobromide

Product NDC: 59651-105
Requested package NDC: 59651-105-69
11-digit product format: 596510105
Labeler code: 59651
Product ID: 59651-105_f505017a-a5d7-4f9a-a62f-06a28b30f645
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eletriptan Hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA210708
Marketing category: ANDA
Marketing start: 2018-02-16
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 43.

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
A210708-001	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB		2019-01-15
A210708-002	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB		2019-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210708-001	AB
A210708-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210708-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210708-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210708-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210708-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210708-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210708-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210708-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210708-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210708-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210708-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210708-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210708-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210708-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210708-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210708-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210708-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210708-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210708-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210708-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210708-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210708-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210708-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210708-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210708-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210708-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210708-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210708-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210708-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210708-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210708-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210708-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210708-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ELETRIPTAN HYDROBROMIDE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M41W832TA3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359493	Internal RxNorm lookup
359494	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
bb5ea5df-4add-420d-88cb-6dabe116ca65	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59651-105-06	Eletriptan Hydrobromide	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	5
59651-105-69	Eletriptan Hydrobromide	1 in 1 CARTON	TABLET, FILM COATED	1	5
59651-105-93	Eletriptan Hydrobromide	2 in 1 CARTON	TABLET, FILM COATED	2	5
59651-105-93	Eletriptan Hydrobromide	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-105-06	EA - Each	59651-105	a5de6b8e-5077-4ec6-8e0c-4ba9fdc85a6f	1	2019-04-11
59651-105-69	EA - Each	59651-105	783cc77f-2b7a-4d78-a85f-6f9f7c2cb004	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-105	ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20240604_bb5ea5df-4add-420d-88cb-6dabe116ca65.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eletriptan HBR	ELETRIPTAN HBR	Direct_Rx	077134d1-427d-6235-e063-6394a90abcf6	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210708 application number: ANDA210708
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Bryant Ranch Prepack	a3953ca6-3da6-4420-9eb5-a16b38372f4e	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210708 application number: ANDA210708
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Advanced Rx of Tennessee, LLC	1bbcb13f-d1cb-82c1-e063-6394a90a7753	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210708 application number: ANDA210708
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Aurobindo Pharma Limited	bb5ea5df-4add-420d-88cb-6dabe116ca65	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210708 application number: ANDA210708 ndc (package): 59651-105-69 ndc (product): 59651-105 ndc11 (package): 59651010569

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
359494	eletriptan HBr 40 MG Oral Tablet	PSN	a3953ca6-3da6-4420-9eb5-a16b38372f4e	1003
359494	eletriptan 40 MG Oral Tablet	SCD	a3953ca6-3da6-4420-9eb5-a16b38372f4e	1003
359494	eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral Tablet	SY	a3953ca6-3da6-4420-9eb5-a16b38372f4e	1003
359493	eletriptan HBr 20 MG Oral Tablet	PSN	bb5ea5df-4add-420d-88cb-6dabe116ca65	5
359494	eletriptan HBr 40 MG Oral Tablet	PSN	bb5ea5df-4add-420d-88cb-6dabe116ca65	5
359493	eletriptan 20 MG Oral Tablet	SCD	bb5ea5df-4add-420d-88cb-6dabe116ca65	5
359494	eletriptan 40 MG Oral Tablet	SCD	bb5ea5df-4add-420d-88cb-6dabe116ca65	5
359493	eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral Tablet	SY	bb5ea5df-4add-420d-88cb-6dabe116ca65	5
359494	eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral Tablet	SY	bb5ea5df-4add-420d-88cb-6dabe116ca65	5
359494	eletriptan HBr 40 MG Oral Tablet	PSN	077134d1-427d-6235-e063-6394a90abcf6	2
359494	eletriptan 40 MG Oral Tablet	SCD	077134d1-427d-6235-e063-6394a90abcf6	2
359494	eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral Tablet	SY	077134d1-427d-6235-e063-6394a90abcf6	2
359494	eletriptan HBr 40 MG Oral Tablet	PSN	1bbcb13f-d1cb-82c1-e063-6394a90a7753	1
359494	eletriptan 40 MG Oral Tablet	SCD	1bbcb13f-d1cb-82c1-e063-6394a90a7753	1
359494	eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral Tablet	SY	1bbcb13f-d1cb-82c1-e063-6394a90a7753	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-105-69	59651010569	1 BLISTER PACK in 1 CARTON (59651-105-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-105-06)	1 blister pack	2019-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eletriptan HBR	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Eletriptan Hydrobromide	Bryant Ranch Prepack	2024-09-13	HUMAN PRESCRIPTION DRUG LABEL	1003
Eletriptan Hydrobromide	Advanced Rx of Tennessee, LLC	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	1
Eletriptan Hydrobromide	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-06-03	Human Prescription Drug Label	5