syndros

Generic: dronabinol

Labeler: benuvia operations, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name syndros
Generic Name dronabinol
Labeler benuvia operations, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dronabinol 5 mg/mL

Manufacturer
Benuvia Operations, LLC

Identifiers & Regulatory

Product NDC 78613-201
Product ID 78613-201_494ff731-1103-5975-e063-6294a90a527b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205525
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2017-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78613201
Hyphenated Format 78613-201

Supplemental Identifiers

RxCUI
1928948 1928954
UPC
0378613201306
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 syndros (source: ndc)
Generic Name dronabinol (source: ndc)
Application Number NDA205525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

78613-201-30 1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS

Ingredients (1)

dronabinol (5 mg/mL)

Linked Drug Pages (1)

SYNDROS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "494ff731-1103-5975-e063-6294a90a527b", "openfda": {"nui": ["N0000175782", "M0003267"], "upc": ["0378613201306"], "unii": ["7J8897W37S"], "rxcui": ["1928948", "1928954"], "spl_set_id": ["a7801c70-995d-46a2-91ee-141ef427c6b5"], "pharm_class_cs": ["Cannabinoids [CS]"], "pharm_class_epc": ["Cannabinoid [EPC]"], "manufacturer_name": ["Benuvia Operations, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (78613-201-30)  / 30 mL in 1 BOTTLE, GLASS", "package_ndc": "78613-201-30", "marketing_start_date": "20170701"}], "brand_name": "SYNDROS", "product_id": "78613-201_494ff731-1103-5975-e063-6294a90a527b", "dosage_form": "SOLUTION", "pharm_class": ["Cannabinoid [EPC]", "Cannabinoids [CS]"], "product_ndc": "78613-201", "dea_schedule": "CII", "generic_name": "Dronabinol", "labeler_name": "Benuvia Operations, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SYNDROS", "active_ingredients": [{"name": "DRONABINOL", "strength": "5 mg/mL"}], "application_number": "NDA205525", "marketing_category": "NDA", "marketing_start_date": "20170701", "listing_expiration_date": "20271231"}