ramelteon

Generic: ramelteon

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-028
Product ID 70010-028_019388a3-ecda-7396-e063-6294a90a62b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213186
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

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 70010028
Hyphenated Format 70010-028

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 ANDA213186 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-028-01)
  • 30 TABLET in 1 BOTTLE (70010-028-03)
  • 500 TABLET in 1 BOTTLE (70010-028-05)
source: ndc

Packages (3)

70010-028-01 100 TABLET in 1 BOTTLE (70010-028-01) 70010-028-03 30 TABLET in 1 BOTTLE (70010-028-03) 70010-028-05 500 TABLET in 1 BOTTLE (70010-028-05)

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": "019388a3-ecda-7396-e063-6294a90a62b6", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["a0a57843-81cb-474d-8e90-e04bbe93216a"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-028-01)", "package_ndc": "70010-028-01", "marketing_start_date": "20230515"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70010-028-03)", "package_ndc": "70010-028-03", "marketing_start_date": "20201001"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70010-028-05)", "package_ndc": "70010-028-05", "marketing_start_date": "20201001"}], "brand_name": "Ramelteon", "product_id": "70010-028_019388a3-ecda-7396-e063-6294a90a62b6", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "70010-028", "generic_name": "Ramelteon", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA213186", "marketing_category": "ANDA", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}