Ramelteon

Product NDC: 70710-1344
11-digit product format: 707101344
Labeler code: 70710
Product ID: 70710-1344_6bc89997-a72b-415e-93d9-442ce2579bca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA211567
Marketing category: ANDA
Marketing start: 2019-07-23
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
RAMELTEON	8 mg/1

Field, Values table
Field	Values
Unii	901AS54I69
Rxcui	577348

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a82c83c-9d80-697e-efb4-23e95bcb1bc2	Product name	8	20240809

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70710-1344-1	Ramelteon	100 in 1 BOTTLE	TABLET	100	4
70710-1344-3	Ramelteon	30 in 1 BOTTLE	TABLET	30	4
70710-1344-5	Ramelteon	500 in 1 BOTTLE	TABLET	500	4

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1344-1	EA - Each	70710-1344	7dd2034b-7ac4-4eb4-8f38-0b026df9c246	1	2019-08-06
70710-1344-3	EA - Each	70710-1344	376c1037-907a-4be6-857c-31b3450d6323	1	2019-08-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1344	RAMELTEON TABLET [ZYDUS PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 3 package rows	20231110_5db0e3ff-fefb-4c54-b9f9-b555e482e147.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
901AS54I69	RAMELTEON	196597-26-9	RAMELTEON

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577348	ramelteon 8 MG Oral Tablet	PSN	bccc4f11-6081-49a1-9abd-2f4c2d69b380	103
577348	ramelteon 8 MG Oral Tablet	SCD	bccc4f11-6081-49a1-9abd-2f4c2d69b380	103
577348	ramelteon 8 MG Oral Tablet	PSN	5db0e3ff-fefb-4c54-b9f9-b555e482e147	4
577348	ramelteon 8 MG Oral Tablet	SCD	5db0e3ff-fefb-4c54-b9f9-b555e482e147	4
577348	ramelteon 8 MG Oral Tablet	PSN	094d5aa0-aa29-4898-928a-fe0d283a5271	3
577348	ramelteon 8 MG Oral Tablet	SCD	094d5aa0-aa29-4898-928a-fe0d283a5271	3
577348	ramelteon 8 MG Oral Tablet	PSN	208dbac2-2634-4aff-8e2c-e5ecb47145e2	2
577348	ramelteon 8 MG Oral Tablet	PSN	44be28b2-f079-40ce-b86d-8b60eda1a7c0	2
577348	ramelteon 8 MG Oral Tablet	PSN	b336438f-7951-d3b7-e053-2995a90a4d69	2
577348	ramelteon 8 MG Oral Tablet	SCD	208dbac2-2634-4aff-8e2c-e5ecb47145e2	2
577348	ramelteon 8 MG Oral Tablet	SCD	44be28b2-f079-40ce-b86d-8b60eda1a7c0	2
577348	ramelteon 8 MG Oral Tablet	SCD	b336438f-7951-d3b7-e053-2995a90a4d69	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70710-1344-1	70710134401	100 TABLET in 1 BOTTLE (70710-1344-1)	100 tablet	2019-07-23	0000-00-00	No	No	Current
70710-1344-3	70710134403	30 TABLET in 1 BOTTLE (70710-1344-3)	30 tablet	2019-07-23	0000-00-00	No	No	Current
70710-1344-5	70710134405	500 TABLET in 1 BOTTLE (70710-1344-5)	500 tablet	2019-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramelteon	Major Pharmaceuticals	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	2
RAMELTEON	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	American Health Packaging	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	3
Ramelteon	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-11-27	HUMAN PRESCRIPTION DRUG LABEL	2
Ramelteon	Bryant Ranch Prepack	2023-11-09	HUMAN PRESCRIPTION DRUG LABEL	103
Ramelteon	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-11-07	HUMAN PRESCRIPTION DRUG LABEL	4