Ramelteon

Product NDC: 10135-838
11-digit product format: 101350838
Labeler code: 10135
Product ID: 10135-838_56d1aa94-e21a-4ed2-e063-6294a90aa714
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc.
Application: ANDA215435
Marketing category: ANDA
Marketing start: 2026-07-01
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215435-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2022-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215435-001	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
2026-09-14 22:38:34	2026-08	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215435-001	RAMELTEON	8MG	TABLET / ORAL		2022-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215435-001	RAMELTEON	8MG	TABLET / ORAL	AB	2022-08-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215435-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215435-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215435-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215435-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215435-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215435-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215435-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215435-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215435-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215435-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215435-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215435-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215435-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215435-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215435-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215435-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215435-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215435-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215435-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215435-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215435-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215435-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215435-001	AB	1	`3f0d92c62455…`
2023-01-26 05:58 UTC	2023-01	A215435-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215435-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215435-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215435-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215435-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
56d1ac8d-5131-4eed-e063-6294a90a402e	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Marlex Pharmaceuticals, Inc.	56d1ac8d-5131-4eed-e063-6294a90a402e	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215435 application number: ANDA215435 ndc (product): 10135-838
Ramelteon	RAMELTEON	Bryant Ranch Prepack	00f0fbda-eb62-4f79-ae9c-286b31eca733	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215435 application number: ANDA215435
Ramelteon	RAMELTEON	Kanchan Healthcare Inc	782503c6-a82f-4933-aa04-399123e9f5a9	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215435 application number: ANDA215435

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	Marketing start	Sample	Exclude flag	Status
10135-838-01	10135083801	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-01)	2026-07-01	No	No	Current
10135-838-30	10135083830	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-30)	2026-07-01	No	No	Current