Ramelteon

Product NDC: 80425-0593
Requested package NDC: 80425-0593-1
11-digit product format: 804250593
Labeler code: 80425
Product ID: 80425-0593_57b24374-73db-2c05-e063-6294a90aae55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA215243
Marketing category: ANDA
Marketing start: 2026-07-27
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC]; Melatonin Receptor Agonists [MoA]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A215243-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2023-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215243-001	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.

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	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215243-001	RAMELTEON	8MG	TABLET / ORAL	AB	2023-02-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215243-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215243-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215243-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215243-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215243-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215243-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215243-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215243-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215243-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215243-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215243-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215243-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215243-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215243-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215243-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215243-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215243-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215243-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215243-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215243-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215243-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215243-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215243-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215243-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ramelteon
Listing expiration: 2027-12-31

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
57b24572-f601-b092-e063-6394a90afa53	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Advanced Rx of Tennessee, LLC	57b24572-f601-b092-e063-6394a90afa53	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215243 application number: ANDA215243 ndc (package): 80425-0593-1 ndc (product): 80425-0593 ndc11 (package): 80425059301
Ramelteon	RAMELTEON	Sportpharm LLC	b4239d09-2cb3-4e7d-b035-995ddcf386df	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215243 application number: ANDA215243
Ramelteon	RAMELTEON	AvPAK	5245f9ee-b4ca-24b6-e063-6394a90a0b1b	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215243 application number: ANDA215243
Ramelteon	RAMELTEON	ASCLEMED USA INC.	f15c8612-4065-4078-bff9-f2ffc1319654	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215243 application number: ANDA215243
Ramelteon	RAMELTEON	Micro Labs Limited	7545c79a-93ea-4f73-beb5-cac46b2ed7e9	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215243 application number: ANDA215243
Ramelteon	RAMELTEON	Bryant Ranch Prepack	4c25cf94-f30e-4940-9f8b-3cb34258ba04	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215243 application number: ANDA215243

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
80425-0593-1	80425059301	30 TABLET in 1 BOTTLE (80425-0593-1)	30 tablet	2026-07-27	0	Current