NDC 78613-201

SYNDROS

Dronabinol

SYNDROS is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Benuvia Therapeutics Inc.. The primary component is Dronabinol.

• Product ID: 78613-201_47babd53-3b15-4b73-ab66-32d4b304bb6b
• NDC: 78613-201
• Product Type: Human Prescription Drug
• Proprietary Name: SYNDROS
• Generic Name: Dronabinol
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA205525
• Labeler Name: Benuvia Therapeutics Inc.
• Substance Name: DRONABINOL
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Cannabinoid [EPC],Cannabinoids [CS]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 78613-201-30

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

• Marketing Start Date: 2017-07-01
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "SYNDROS" or generic name "Dronabinol"

NDC	Brand Name	Generic Name
20482-335	SYNDROS	SYNDROS
78613-201	SYNDROS	SYNDROS
0527-1450	Dronabinol	Dronabinol
0527-1451	Dronabinol	Dronabinol
0527-1452	Dronabinol	Dronabinol
0527-4125	DRONABINOL	dronabinol
0591-3591	Dronabinol	Dronabinol
0591-3592	Dronabinol	Dronabinol
0591-3593	Dronabinol	Dronabinol
0904-6597	Dronabinol	Dronabinol
0904-6598	Dronabinol	Dronabinol
0904-6745	DRONABINOL	DRONABINOL
0904-6746	DRONABINOL	DRONABINOL
0904-7068	Dronabinol	Dronabinol
0904-7144	Dronabinol	Dronabinol
0904-7145	Dronabinol	Dronabinol
17478-761	Dronabinol	Dronabinol
17478-762	Dronabinol	Dronabinol
17478-763	Dronabinol	Dronabinol
0051-0021	Marinol	Dronabinol
0051-0022	Marinol	Dronabinol
0051-0023	Marinol	Dronabinol