Eletriptan HBR

Product NDC: 72189-517
Requested package NDC: 72189-517-06
11-digit product format: 721890517
Labeler code: 72189
Product ID: 72189-517_2c4e7a35-ff54-4971-e063-6294a90ae9df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eletriptan HBR
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA210708
Marketing category: ANDA
Marketing start: 2023-10-11
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-517	72189-517-06	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-517	72189-517-06	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A210708-001	ELETRIPTAN HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-01-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210708-002	ELETRIPTAN HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2019-01-15	`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	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…`
2022-03-09 01:35 UTC	2022-03	A210708-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210708-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Eletriptan HBR
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
077134d1-427d-6235-e063-6394a90abcf6	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	Strength	SPL version
72189-517-06	Eletriptan HBR	6 in 1 CARTON	TABLET, FILM COATED	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-517	ELETRIPTAN HBR TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_077134d1-427d-6235-e063-6394a90abcf6.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 ndc (package): 72189-517-06 ndc (product): 72189-517 ndc11 (package): 72189051706
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

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-517-06	72189051706	6 TABLET, FILM COATED in 1 CARTON (72189-517-06)	2023-10-11	No	No	Current