Ramelteon

Product NDC: 70010-028
11-digit product format: 700100028
Labeler code: 70010
Product ID: 70010-028_019388a3-ecda-7396-e063-6294a90a62b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA213186
Marketing category: ANDA
Marketing start: 2020-10-01
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	70010-028		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	70010-028	70010-028-22	UNFINISHED	Active or certified unfinished drug listing		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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	70010-028-22	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	70010-028-22	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	70010-028-22	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	70010-028-22	`e30019b0c005…`	`a3f0b14938b7…`

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
A213186-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL			2020-08-21

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	A213186-001	RAMELTEON	8MG	TABLET / ORAL		2020-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL		2020-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL		2020-08-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A213186-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213186-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213186-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213186-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213186-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213186-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213186-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213186-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213186-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213186-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213186-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213186-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213186-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213186-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213186-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213186-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213186-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213186-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213186-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213186-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213186-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213186-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213186-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213186-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213186-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213186-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213186-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213186-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213186-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213186-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213186-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213186-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213186-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213186-001	AB	1	`cb3db0bc1861…`

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
a0a57843-81cb-474d-8e90-e04bbe93216a	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	SPL version
70010-028-01	Ramelteon	100 in 1 BOTTLE	TABLET	100	7
70010-028-03	Ramelteon	30 in 1 BOTTLE	TABLET	30	7
70010-028-05	Ramelteon	500 in 1 BOTTLE	TABLET	500	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-028	RAMELTEON TABLET [GRANULES PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 3 package rows	20230729_a0a57843-81cb-474d-8e90-e04bbe93216a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	AvKARE	b6fc0db5-c68f-5af9-e053-2a95a90a5110	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186
Ramelteon	RAMELTEON	Bryant Ranch Prepack	af1db3bf-1c7c-441e-8497-7c35f45fb00e	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186
Ramelteon	RAMELTEON	Granules Pharmaceuticals Inc.	a0a57843-81cb-474d-8e90-e04bbe93216a	2023-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186 ndc (product): 70010-028
Ramelteon	RAMELTEON	Proficient Rx LP	7ca849d3-f0ba-45b5-9aec-f4b7ea105fac	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186

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	af1db3bf-1c7c-441e-8497-7c35f45fb00e	104
577348	ramelteon 8 MG Oral Tablet	SCD	af1db3bf-1c7c-441e-8497-7c35f45fb00e	104
577348	ramelteon 8 MG Oral Tablet	PSN	a0a57843-81cb-474d-8e90-e04bbe93216a	7
577348	ramelteon 8 MG Oral Tablet	SCD	a0a57843-81cb-474d-8e90-e04bbe93216a	7
577348	ramelteon 8 MG Oral Tablet	PSN	b6fc0db5-c68f-5af9-e053-2a95a90a5110	4
577348	ramelteon 8 MG Oral Tablet	SCD	b6fc0db5-c68f-5af9-e053-2a95a90a5110	4
577348	ramelteon 8 MG Oral Tablet	PSN	7ca849d3-f0ba-45b5-9aec-f4b7ea105fac	3
577348	ramelteon 8 MG Oral Tablet	SCD	7ca849d3-f0ba-45b5-9aec-f4b7ea105fac	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-028-01	70010002801	100 TABLET in 1 BOTTLE (70010-028-01)	100 tablet	2023-05-15	0000-00-00	No	No	Current
70010-028-03	70010002803	30 TABLET in 1 BOTTLE (70010-028-03)	30 tablet	2020-10-01	0000-00-00	No	No	Current
70010-028-05	70010002805	500 TABLET in 1 BOTTLE (70010-028-05)	500 tablet	2020-10-01	0000-00-00	No	No	Current
70010-028-22	70010002822	60000 TABLET in 1 PAIL (70010-028-22)	60000 tablet	2020-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	AvKARE	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	4
Ramelteon	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	104
Ramelteon	Granules Pharmaceuticals Inc.	2023-07-28	HUMAN PRESCRIPTION DRUG LABEL	7
Ramelteon	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	3