Ramelteon

Product NDC: 50436-3980
Requested package NDC: 50436-3980-1
11-digit product format: 504363980
Labeler code: 50436
Product ID: 50436-3980_8825c625-8207-473f-acaa-594265e682d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA212650
Marketing category: ANDA
Marketing start: 2020-06-30
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	50436-3980	50436-3980-1	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
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…`

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
50436-3980-1	2024-01-30	C162847	48780-1	1030e365-0992-111a-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: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-3980-1	Ramelteon	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-3980-1	EA - Each	50436-3980	64472e2c-5957-4eda-94a5-e8e713c88312	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3980	RAMELTEON TABLET, FILM COATED [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20221018_fdafa6f9-0872-48cc-9ed6-7c3f51b21411.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

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	fdafa6f9-0872-48cc-9ed6-7c3f51b21411	2
577348	ramelteon 8 MG Oral Tablet	SCD	fdafa6f9-0872-48cc-9ed6-7c3f51b21411	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-3980-1	50436398001	30 TABLET, FILM COATED in 1 BOTTLE (50436-3980-1)	2020-06-30	0000-00-00	No	No	Current