ramelteon

Generic: ramelteon

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1250
Product ID 0832-1250_47e23ded-379f-0ed4-e063-6394a90ab270
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213815
Listing Expiration 2027-12-31
Marketing Start 2020-10-26

Pharmacologic Class

Established (EPC)
melatonin receptor agonist [epc]
Mechanism of Action
melatonin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08321250
Hyphenated Format 0832-1250

Supplemental Identifiers

RxCUI
577348
UNII
901AS54I69
NUI
N0000175743 N0000000250

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ramelteon (source: ndc)
Generic Name ramelteon (source: ndc)
Application Number ANDA213815 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30)
source: ndc

Packages (2)

0832-1250-11 100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11) 0832-1250-30 30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30)

Ingredients (1)

ramelteon (8 mg/1)

Linked Drug Pages (1)

Ramelteon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e23ded-379f-0ed4-e063-6394a90ab270", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["2d22e6ae-2373-4a2f-8dda-d223230c6010"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11)", "package_ndc": "0832-1250-11", "marketing_start_date": "20201026"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30)", "package_ndc": "0832-1250-30", "marketing_start_date": "20201026"}], "brand_name": "Ramelteon", "product_id": "0832-1250_47e23ded-379f-0ed4-e063-6394a90ab270", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "0832-1250", "generic_name": "Ramelteon", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA213815", "marketing_category": "ANDA", "marketing_start_date": "20201026", "listing_expiration_date": "20271231"}