dronabinol

Generic: dronabinol

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dronabinol
Generic Name dronabinol
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dronabinol 5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7145
Product ID 0904-7145_66386fe7-e73f-436c-8a56-8b8cd31e4eda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA018651
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2021-03-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047145
Hyphenated Format 0904-7145

Supplemental Identifiers

RxCUI
197635 197636
UNII
7J8897W37S
NUI
N0000175782 M0003267

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 NDA018651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7145-04) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7145-04 30 BLISTER PACK in 1 CARTON (0904-7145-04) / 1 CAPSULE in 1 BLISTER PACK

Ingredients (1)

dronabinol (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": "66386fe7-e73f-436c-8a56-8b8cd31e4eda", "openfda": {"nui": ["N0000175782", "M0003267"], "unii": ["7J8897W37S"], "rxcui": ["197635", "197636"], "spl_set_id": ["fd8c5d57-0173-4f62-8ff0-d8147986a976"], "pharm_class_cs": ["Cannabinoids [CS]"], "pharm_class_epc": ["Cannabinoid [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7145-04)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7145-04", "marketing_start_date": "20210303"}], "brand_name": "Dronabinol", "product_id": "0904-7145_66386fe7-e73f-436c-8a56-8b8cd31e4eda", "dosage_form": "CAPSULE", "pharm_class": ["Cannabinoid [EPC]", "Cannabinoids [CS]"], "product_ndc": "0904-7145", "dea_schedule": "CIII", "generic_name": "Dronabinol", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dronabinol", "active_ingredients": [{"name": "DRONABINOL", "strength": "5 mg/1"}], "application_number": "NDA018651", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20210303", "listing_expiration_date": "20261231"}