RAMELTEON

Product NDC: 72189-153
11-digit product format: 721890153
Labeler code: 72189
Product ID: 72189-153_2be9051e-225a-8882-e063-6294a90a543a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RAMELTEON
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA211567
Marketing category: ANDA
Marketing start: 2020-11-03
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

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
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-153		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-153	72189-153-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A211567-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2019-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211567-001	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	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`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	A211567-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211567-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211567-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211567-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211567-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211567-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211567-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211567-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211567-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211567-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211567-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211567-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211567-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211567-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211567-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211567-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211567-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211567-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211567-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211567-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211567-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211567-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211567-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211567-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211567-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211567-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211567-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211567-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211567-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211567-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211567-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211567-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211567-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211567-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211567-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211567-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211567-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211567-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211567-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211567-001	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
b336438f-7951-d3b7-e053-2995a90a4d69	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
72189-153-30	RAMELTEON	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-153-30	EA - Each	72189-153	af50ec73-0ce9-46ce-97ee-fbf94d076432	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-153	RAMELTEON TABLET [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250119_b336438f-7951-d3b7-e053-2995a90a4d69.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Major Pharmaceuticals	44be28b2-f079-40ce-b86d-8b60eda1a7c0	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
RAMELTEON	RAMELTEON	DIRECT RX	b336438f-7951-d3b7-e053-2995a90a4d69	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567 ndc (product): 72189-153
Ramelteon	RAMELTEON	Zydus Lifesciences Limited	14ba7994-476a-4978-8cac-29989335a63c	2024-12-04		Exact identifier application applno (ANDA): 211567 application number: ANDA211567
Ramelteon	RAMELTEON	American Health Packaging	094d5aa0-aa29-4898-928a-fe0d283a5271	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
Ramelteon	RAMELTEON	Asclemed USA, Inc.	208dbac2-2634-4aff-8e2c-e5ecb47145e2	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
Ramelteon	RAMELTEON	Bryant Ranch Prepack	bccc4f11-6081-49a1-9abd-2f4c2d69b380	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
Ramelteon	RAMELTEON	Zydus Pharmaceuticals USA Inc.	5db0e3ff-fefb-4c54-b9f9-b555e482e147	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567

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	b336438f-7951-d3b7-e053-2995a90a4d69	2
577348	ramelteon 8 MG Oral Tablet	SCD	b336438f-7951-d3b7-e053-2995a90a4d69	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-153-30	72189015330	30 TABLET in 1 BOTTLE (72189-153-30)	30 tablet	2020-11-03	0000-00-00	No	No	Current