Ramelteon

Product NDC: 0591-2191
Requested package NDC: 0591-2191-00
11-digit product format: 005912191
Labeler code: 0591
Product ID: 0591-2191_181ea308-f62b-48a0-81fc-a4654d679adb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA091610
Marketing category: ANDA
Marketing start: 2019-07-22
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0591-2191	0591-2191-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 19 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091610-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2015-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091610-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091610-001	RAMELTEON	8MG	TABLET / ORAL	AB	2015-08-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091610-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091610-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091610-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091610-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091610-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091610-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091610-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091610-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091610-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091610-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091610-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091610-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091610-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091610-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091610-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091610-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091610-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091610-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091610-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091610-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091610-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091610-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091610-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091610-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091610-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091610-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091610-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091610-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091610-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091610-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091610-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091610-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091610-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091610-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091610-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091610-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091610-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091610-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091610-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091610-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RAMELTEON	8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901AS54I69	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
577348	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
a89dae05-6c39-4072-b8ee-c4c35b46f7d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a82c83c-9d80-697e-efb4-23e95bcb1bc2	Product name	8	20240809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2191-01	Ramelteon	100 in 1 BOTTLE	TABLET	100		14
0591-2191-30	Ramelteon	30 in 1 BOTTLE	TABLET	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2191-01	EA - Each	0591-2191	d28250f3-c7d9-4596-9f57-524402098524	1	2019-08-06
0591-2191-30	EA - Each	0591-2191	a25d3cc9-acc3-4bdb-9bfb-cae279e8b897	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2191	RAMELTEON TABLET [ACTAVIS PHARMA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20240302_a89dae05-6c39-4072-b8ee-c4c35b46f7d4.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
Ramelteon	RAMELTEON	Actavis Pharma, Inc.	a89dae05-6c39-4072-b8ee-c4c35b46f7d4	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091610 application number: ANDA091610 ndc (product): 0591-2191

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
901AS54I69	RAMELTEON	196597-26-9	RAMELTEON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577348	ramelteon 8 MG Oral Tablet	PSN	a89dae05-6c39-4072-b8ee-c4c35b46f7d4	14
577348	ramelteon 8 MG Oral Tablet	SCD	a89dae05-6c39-4072-b8ee-c4c35b46f7d4	14
577348	ramelteon 8 MG Oral Tablet	PSN	13b7eab3-05af-42a8-a4a0-a9ace7004632	2
577348	ramelteon 8 MG Oral Tablet	SCD	13b7eab3-05af-42a8-a4a0-a9ace7004632	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
0591-2191-00	00591219100	69348 TABLET in 1 BOX (0591-2191-00)	69348 tablet	22-JUL-19	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	Bryant Ranch Prepack	2022-04-29	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	Actavis Pharma, Inc.	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	14