Ramelteon

Product NDC: 0832-1250
11-digit product format: 008321250
Labeler code: 0832
Product ID: 0832-1250_47e23ded-379f-0ed4-e063-6394a90ab270
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA213815
Marketing category: ANDA
Marketing start: 2020-10-26
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 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
A213815-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2020-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213815-001	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	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213815-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-10-26	`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	A213815-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213815-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213815-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213815-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213815-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213815-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213815-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213815-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213815-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213815-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213815-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213815-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213815-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213815-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213815-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213815-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213815-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213815-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213815-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213815-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213815-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213815-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213815-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213815-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213815-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213815-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213815-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213815-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213815-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213815-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213815-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213815-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213815-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213815-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213815-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213815-001	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
2d22e6ae-2373-4a2f-8dda-d223230c6010	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	Strength	SPL version
0832-1250-11	Ramelteon	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
0832-1250-30	Ramelteon	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-1250-11	EA - Each	0832-1250	b184cb6e-c06e-4467-94ca-890bf7b7c811	1	2021-01-08
0832-1250-30	EA - Each	0832-1250	dbe0ad62-3235-4f55-967f-a923d287669a	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-1250	RAMELTEON TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20230331_2d22e6ae-2373-4a2f-8dda-d223230c6010.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Bryant Ranch Prepack	86296f99-efef-4cbb-84cb-097b2edcfe9c	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213815 application number: ANDA213815
Ramelteon	RAMELTEON	Upsher-Smith Laboratories, LLC	2d22e6ae-2373-4a2f-8dda-d223230c6010	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213815 application number: ANDA213815 ndc (product): 0832-1250
Ramelteon	RAMELTEON	REMEDYREPACK INC.	5a3cf917-3569-4fc1-8b81-ffecfd2de005	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213815 application number: ANDA213815
Ramelteon	RAMELTEON	Direct_Rx	fd169dd8-70a0-b6b4-e053-6394a90a3a6f	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213815 application number: ANDA213815
Ramelteon	RAMELTEON	Advanced Rx Pharmacy of Tennessee, LLC	fe2fc3b7-4600-c14e-e053-6394a90a2586	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213815 application number: ANDA213815

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	86296f99-efef-4cbb-84cb-097b2edcfe9c	102
577348	ramelteon 8 MG Oral Tablet	SCD	86296f99-efef-4cbb-84cb-097b2edcfe9c	102
577348	ramelteon 8 MG Oral Tablet	PSN	2d22e6ae-2373-4a2f-8dda-d223230c6010	4
577348	ramelteon 8 MG Oral Tablet	SCD	2d22e6ae-2373-4a2f-8dda-d223230c6010	4
577348	ramelteon 8 MG Oral Tablet	PSN	5a3cf917-3569-4fc1-8b81-ffecfd2de005	2
577348	ramelteon 8 MG Oral Tablet	PSN	fd169dd8-70a0-b6b4-e053-6394a90a3a6f	2
577348	ramelteon 8 MG Oral Tablet	PSN	fe2fc3b7-4600-c14e-e053-6394a90a2586	2
577348	ramelteon 8 MG Oral Tablet	SCD	5a3cf917-3569-4fc1-8b81-ffecfd2de005	2
577348	ramelteon 8 MG Oral Tablet	SCD	fd169dd8-70a0-b6b4-e053-6394a90a3a6f	2
577348	ramelteon 8 MG Oral Tablet	SCD	fe2fc3b7-4600-c14e-e053-6394a90a2586	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-1250-11	00832125011	100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11)	2020-10-26	0000-00-00	No	No	Current
0832-1250-30	00832125030	30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30)	2020-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	Bryant Ranch Prepack	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	102
Ramelteon	Upsher-Smith Laboratories, LLC \| Appco Pharma LLC	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	4
Ramelteon	REMEDYREPACK INC.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2