dronabinol

Generic: dronabinol

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dronabinol
Generic Name dronabinol
Labeler rhodes pharmaceuticals l.p.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dronabinol 10 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-869
Product ID 42858-869_3b651e63-d7f6-4256-a7a8-d4ceb23aed92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078292
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2018-06-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858869
Hyphenated Format 42858-869

Supplemental Identifiers

RxCUI
197634 197635 197636
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 ANDA078292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (42858-869-06)
source: ndc

Packages (1)

42858-869-06 60 CAPSULE in 1 BOTTLE (42858-869-06)

Ingredients (1)

dronabinol (10 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": "3b651e63-d7f6-4256-a7a8-d4ceb23aed92", "openfda": {"nui": ["N0000175782", "M0003267"], "unii": ["7J8897W37S"], "rxcui": ["197634", "197635", "197636"], "spl_set_id": ["3c06ccda-4819-40f8-b2db-fa294bb8a2fa"], "pharm_class_cs": ["Cannabinoids [CS]"], "pharm_class_epc": ["Cannabinoid [EPC]"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (42858-869-06)", "package_ndc": "42858-869-06", "marketing_start_date": "20180626"}], "brand_name": "DRONABINOL", "product_id": "42858-869_3b651e63-d7f6-4256-a7a8-d4ceb23aed92", "dosage_form": "CAPSULE", "pharm_class": ["Cannabinoid [EPC]", "Cannabinoids [CS]"], "product_ndc": "42858-869", "dea_schedule": "CIII", "generic_name": "DRONABINOL", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DRONABINOL", "active_ingredients": [{"name": "DRONABINOL", "strength": "10 mg/1"}], "application_number": "ANDA078292", "marketing_category": "ANDA", "marketing_start_date": "20180626", "listing_expiration_date": "20261231"}