Ramelteon

Product NDC: 42571-375
11-digit product format: 425710375
Labeler code: 42571
Product ID: 42571-375_336c8c9f-7af0-d608-e063-6394a90a5e21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA215243
Marketing category: ANDA
Marketing start: 2023-05-01
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

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
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
2026-02-19 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
2026-02-19 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: 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
7545c79a-93ea-4f73-beb5-cac46b2ed7e9	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	SPL version
42571-375-01	Ramelteon	100 in 1 BOTTLE	TABLET	100	2
42571-375-05	Ramelteon	500 in 1 BOTTLE	TABLET	500	2
42571-375-30	Ramelteon	30 in 1 BOTTLE	TABLET	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-375-01	EA - Each	42571-375	b2b8f8f2-f1fd-4165-a5fd-7462ff6c26f7	1	2023-10-16
42571-375-30	EA - Each	42571-375	06206768-b55d-4f40-8505-f07655d22469	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-375	RAMELTEON TABLET [MICRO LABS LIMITED]	2	Current NDC, 3 package rows	20250424_7545c79a-93ea-4f73-beb5-cac46b2ed7e9.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 · 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
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 ndc (product): 42571-375
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577348	ramelteon 8 MG Oral Tablet	PSN	4c25cf94-f30e-4940-9f8b-3cb34258ba04	100
577348	ramelteon 8 MG Oral Tablet	SCD	4c25cf94-f30e-4940-9f8b-3cb34258ba04	100
577348	ramelteon 8 MG Oral Tablet	PSN	5245f9ee-b4ca-24b6-e063-6394a90a0b1b	2
577348	ramelteon 8 MG Oral Tablet	PSN	7545c79a-93ea-4f73-beb5-cac46b2ed7e9	2
577348	ramelteon 8 MG Oral Tablet	SCD	5245f9ee-b4ca-24b6-e063-6394a90a0b1b	2
577348	ramelteon 8 MG Oral Tablet	SCD	7545c79a-93ea-4f73-beb5-cac46b2ed7e9	2
577348	ramelteon 8 MG Oral Tablet	PSN	f15c8612-4065-4078-bff9-f2ffc1319654	1
577348	ramelteon 8 MG Oral Tablet	SCD	f15c8612-4065-4078-bff9-f2ffc1319654	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42571-375-01	42571037501	100 TABLET in 1 BOTTLE (42571-375-01)	100 tablet	2023-05-01	No	No	Current
42571-375-05	42571037505	500 TABLET in 1 BOTTLE (42571-375-05)	500 tablet	2023-05-01	No	No	Current
42571-375-30	42571037530	30 TABLET in 1 BOTTLE (42571-375-30)	30 tablet	2023-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	Advanced Rx of Tennessee, LLC	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	1
Ramelteon	Sportpharm LLC \| ASCLEMED USA INC. DBA ENOVACHEM	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	1
Ramelteon	AvPAK	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	1
Ramelteon	Micro Labs Limited	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	Bryant Ranch Prepack	2023-12-18	HUMAN PRESCRIPTION DRUG LABEL	100