dronabinol

Generic: dronabinol

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dronabinol
Generic Name dronabinol
Labeler lannett company, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dronabinol 2.5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-4125
Product ID 0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207421
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-02-10

Pharmacologic Class

Established (EPC)
cannabinoid [epc]
Chemical Structure
cannabinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05274125
Hyphenated Format 0527-4125

Supplemental Identifiers

RxCUI
197635
UPC
0305274125351
UNII
7J8897W37S
NUI
N0000175782 M0003267

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 dronabinol (source: ndc)
Generic Name dronabinol (source: ndc)
Application Number ANDA207421 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (0527-4125-35)
source: ndc

Packages (1)

0527-4125-35 60 CAPSULE in 1 BOTTLE (0527-4125-35)

Ingredients (1)

dronabinol (2.5 mg/1)

Linked Drug Pages (1)

DRONABINOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aac4561c-b9ba-4d3a-b86c-be120e4593dc", "openfda": {"nui": ["N0000175782", "M0003267"], "upc": ["0305274125351"], "unii": ["7J8897W37S"], "rxcui": ["197635"], "spl_set_id": ["c51d327b-51cc-408d-b0b3-fde5389294d0"], "pharm_class_cs": ["Cannabinoids [CS]"], "pharm_class_epc": ["Cannabinoid [EPC]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0527-4125-35)", "package_ndc": "0527-4125-35", "marketing_start_date": "20200210"}], "brand_name": "DRONABINOL", "product_id": "0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc", "dosage_form": "CAPSULE", "pharm_class": ["Cannabinoid [EPC]", "Cannabinoids [CS]"], "product_ndc": "0527-4125", "dea_schedule": "CIII", "generic_name": "dronabinol", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DRONABINOL", "active_ingredients": [{"name": "DRONABINOL", "strength": "2.5 mg/1"}], "application_number": "ANDA207421", "marketing_category": "ANDA", "marketing_start_date": "20200210", "listing_expiration_date": "20261231"}