Ramelteon

Product NDC: 43598-741
11-digit product format: 435980741
Labeler code: 43598
Product ID: 43598-741_54220029-c5df-b277-af7e-2786da03bbed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Dr.Reddys Laboratories Inc
Application: ANDA091693
Marketing category: ANDA
Marketing start: 2019-07-22
Marketing end: 2026-07-31
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43598-741		D	Discontinued by firm	2026-08-07
excluded package	package	43598-741	43598-741-01	D	Discontinued by firm	2026-08-07
excluded package	package	43598-741	43598-741-10	D	Discontinued by firm	2026-08-07
excluded package	package	43598-741	43598-741-30	D	Discontinued by firm	2026-08-07

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43598-741	43598-741-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43598-741	43598-741-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A091693-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2013-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091693-001	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.

Product history page 1 of 2 · 41 observed 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	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091693-001	RAMELTEON	8MG	TABLET / ORAL	AB	2013-07-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091693-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091693-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091693-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091693-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091693-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091693-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091693-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091693-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091693-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091693-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091693-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091693-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091693-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091693-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091693-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091693-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091693-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091693-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091693-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091693-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091693-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091693-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091693-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091693-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091693-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091693-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091693-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091693-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091693-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091693-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091693-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091693-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091693-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091693-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091693-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091693-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091693-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091693-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091693-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091693-001	AB	1	`cb3db0bc1861…`

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
43598-741-01	Ramelteon	100 in 1 BOTTLE	TABLET	100	4
43598-741-10	Ramelteon	1000 in 1 BOTTLE	TABLET	1000	4
43598-741-30	Ramelteon	30 in 1 BOTTLE	TABLET	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-741-01	EA - Each	43598-741	007d1ce5-b327-47a2-9ce9-fe3feabcad35	1	2019-08-06
43598-741-30	EA - Each	43598-741	3a42cee4-cb8f-48f0-9025-919b6de11665	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-741	RAMELTEON TABLET [DR.REDDYS LABORATORIES INC]	3	Current NDC, Legacy NDC, 3 package rows	20220304_b71cd925-1bae-5a6a-072b-941ad6d3ce65.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Bryant Ranch Prepack	57536bd9-7dfa-4be5-854a-95fea43d54bc	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091693 application number: ANDA091693

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	57536bd9-7dfa-4be5-854a-95fea43d54bc	100
577348	ramelteon 8 MG Oral Tablet	SCD	57536bd9-7dfa-4be5-854a-95fea43d54bc	100
577348	ramelteon 8 MG Oral Tablet	PSN	b83cb374-8b38-1e35-e053-2995a90aa527	5
577348	ramelteon 8 MG Oral Tablet	SCD	b83cb374-8b38-1e35-e053-2995a90aa527	5
577348	ramelteon 8 MG Oral Tablet	PSN	b71cd925-1bae-5a6a-072b-941ad6d3ce65	4
577348	ramelteon 8 MG Oral Tablet	SCD	b71cd925-1bae-5a6a-072b-941ad6d3ce65	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-741-01	43598074101	100 TABLET in 1 BOTTLE (43598-741-01)	100 tablet	2019-07-22	2026-07-31	No	No	Current
43598-741-10	43598074110	1000 TABLET in 1 BOTTLE (43598-741-10)	1000 tablet	2019-07-22	0000-00-00	No	No	Current
43598-741-30	43598074130	30 TABLET in 1 BOTTLE (43598-741-30)	30 tablet	2019-07-22	2026-07-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	AvPAK	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	5
Ramelteon	Bryant Ranch Prepack	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	100
Ramelteon	Golden State Medical Supply, Inc.	2022-04-11	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	Dr.Reddys Laboratories Inc	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	4