Ramelteon

Product NDC: 63629-8264
Requested package NDC: 63629-8264-2
11-digit product format: 636298264
Labeler code: 63629
Product ID: 63629-8264_e953b8e0-4a70-4e7b-84d1-e6cc6cce4afb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091610
Marketing category: ANDA
Marketing start: 2019-07-22
Marketing end: 0000-00-00
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-8264	63629-8264-2	I	Inactivated by FDA		2026-08-03

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 · 15 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-8264-1	2024-01-30	C162847	48780-1	1030e365-25e1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 200 5
63629-8264-2	2024-01-30	C162847	48780-1	1030e365-25e1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 200 5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8264-1	Ramelteon	30 in 1 BOTTLE	TABLET	30		2
63629-8264-2	Ramelteon	60 in 1 BOTTLE	TABLET	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8264	RAMELTEON TABLET [BRYANT RANCH PREPACK]	2	Legacy NDC, 2 package rows	20220507_13b7eab3-05af-42a8-a4a0-a9ace7004632.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

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	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	Marketing end	Sample	Exclude flag	Status
63629-8264-2	63629826402	60 TABLET in 1 BOTTLE (63629-8264-2)	60 tablet	2022-04-29	0000-00-00	No	No	Current