Ramelteon

Product NDC: 52817-235
11-digit product format: 528170235
Labeler code: 52817
Product ID: 52817-235_06ea67d8-b615-776b-e063-6294a90a3185
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TruPharma, LLC
Application: ANDA212650
Marketing category: ANDA
Marketing start: 2020-06-30
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
A212650-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2020-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212650-001	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	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	BX	2020-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212650-001	RAMELTEON	8MG	TABLET / ORAL	BX	2020-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`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	A212650-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212650-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212650-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212650-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212650-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212650-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212650-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212650-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212650-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212650-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212650-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212650-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212650-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212650-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212650-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212650-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212650-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212650-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212650-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212650-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212650-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212650-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212650-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212650-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212650-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212650-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212650-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212650-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212650-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212650-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212650-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212650-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212650-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212650-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212650-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212650-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212650-001	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
3d0cc378-4bc5-425c-8f41-43eb734c24d9	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52817-235-10	Ramelteon	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		7
52817-235-30	Ramelteon	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-235-10	EA - Each	52817-235	5c7760e8-c097-4be0-806b-65e6fe289a1d	1	2020-08-06
52817-235-30	EA - Each	52817-235	362962a7-ff51-40b0-902c-64ccb3752b47	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-235	RAMELTEON TABLET, FILM COATED [TRUPHARMA, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20231005_3d0cc378-4bc5-425c-8f41-43eb734c24d9.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Bryant Ranch Prepack	b1706aa1-9332-4faf-8d0c-88edd00b15e3	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Bryant Ranch Prepack	3c14d79c-ece1-40c7-b725-eeb85d6f347a	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Proficient Rx LP	2cb1b48a-05c0-4058-8ccd-1971098b8ce1	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Direct_Rx	e55aea01-80e6-60ae-e053-2995a90a9ca2	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Advanced Rx Pharmacy of Tennessee, LLC	ed37ac7c-ab7e-57b3-e053-2995a90a5b90	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Bryant Ranch Prepack	4d6ad234-69ae-4e33-824d-cff5d1500a86	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	i3 Pharmaceuticals, LLC	32c52e03-4c2e-4774-9397-f1f0ee99b320	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	TruPharma, LLC	3d0cc378-4bc5-425c-8f41-43eb734c24d9	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650 ndc (product): 52817-235

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	3c14d79c-ece1-40c7-b725-eeb85d6f347a	103
577348	ramelteon 8 MG Oral Tablet	SCD	3c14d79c-ece1-40c7-b725-eeb85d6f347a	103
577348	ramelteon 8 MG Oral Tablet	PSN	4d6ad234-69ae-4e33-824d-cff5d1500a86	101
577348	ramelteon 8 MG Oral Tablet	SCD	4d6ad234-69ae-4e33-824d-cff5d1500a86	101
577348	ramelteon 8 MG Oral Tablet	PSN	b1706aa1-9332-4faf-8d0c-88edd00b15e3	100
577348	ramelteon 8 MG Oral Tablet	SCD	b1706aa1-9332-4faf-8d0c-88edd00b15e3	100
577348	ramelteon 8 MG Oral Tablet	PSN	3d0cc378-4bc5-425c-8f41-43eb734c24d9	7
577348	ramelteon 8 MG Oral Tablet	SCD	3d0cc378-4bc5-425c-8f41-43eb734c24d9	7
577348	ramelteon 8 MG Oral Tablet	PSN	e55aea01-80e6-60ae-e053-2995a90a9ca2	3
577348	ramelteon 8 MG Oral Tablet	PSN	ed37ac7c-ab7e-57b3-e053-2995a90a5b90	3
577348	ramelteon 8 MG Oral Tablet	SCD	e55aea01-80e6-60ae-e053-2995a90a9ca2	3
577348	ramelteon 8 MG Oral Tablet	SCD	ed37ac7c-ab7e-57b3-e053-2995a90a5b90	3
577348	ramelteon 8 MG Oral Tablet	PSN	fdafa6f9-0872-48cc-9ed6-7c3f51b21411	2
577348	ramelteon 8 MG Oral Tablet	SCD	fdafa6f9-0872-48cc-9ed6-7c3f51b21411	2
577348	ramelteon 8 MG Oral Tablet	PSN	2cb1b48a-05c0-4058-8ccd-1971098b8ce1	1
577348	ramelteon 8 MG Oral Tablet	SCD	2cb1b48a-05c0-4058-8ccd-1971098b8ce1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52817-235-10	52817023510	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-10)	2020-06-30	0000-00-00	No	No	Current
52817-235-30	52817023530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30)	2020-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	Bryant Ranch Prepack	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	100
Ramelteon	Bryant Ranch Prepack	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	103
Ramelteon	Proficient Rx LP	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	1
Ramelteon	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
Ramelteon Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3
Ramelteon	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Ramelteon	Bryant Ranch Prepack	2023-11-09	HUMAN PRESCRIPTION DRUG LABEL	101
Ramelteon	TruPharma, LLC \| i3 Pharmceuticals, LLC	2023-04-28	HUMAN PRESCRIPTION DRUG LABEL	7
Ramelteon	Unit Dose Services	2022-10-17	HUMAN PRESCRIPTION DRUG LABEL	2