0904-6598 : Dronabinol 5 mg Oral Capsule


NDC: 0904-6598
Labeler: Major Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name: Dronabinol
Dosage Form: Oral Capsule
Application #: ANDA078292
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: PAR;868
Shapes:  Capsule
Colors:  Brown
Size (mm): 12
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

PAR 868: (68084-175) Dronabinol 5 mg Oral Capsule by Major Pharmaceuticals
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0904-6598-04: 30 BLISTER PACK IN 1 CARTON (0904‑6598‑04) > 1 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Dronabinol

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Fd&c Yellow No. 6
  • Gelatin, Unspecified
  • Glycerin
  • Water
  • Sesame Oil
  • Titanium Dioxide
  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Ferrosoferric Oxide
  • Shellac
  • Isopropyl Alcohol
  • Butyl Alcohol
  • Propylene Glycol
  • Ammonia

Pharmaceutical Classes:

  • Cannabinoid [EPC]
  • Cannabinoids [CS]

Related Products:

Based on records with the same trade name.
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  • 0904-6745 Dronabinol 2.5 mg Oral Capsule by Major Pharmaceuticals
  • 0904-6746 Dronabinol 5 mg Oral Capsule by Major Pharmaceuticals
  • 0904-7068 Dronabinol 2.5 mg Oral Capsule by Major Pharmaceuticals
  • 0904-7144 Dronabinol 2.5 mg Oral Capsule by Major Pharmaceuticals
  • 0904-7145 Dronabinol 5 mg Oral Capsule by Major Pharmaceuticals
  • 0378-8170 Dronabinol 2.5 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-8171 Dronabinol 5 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-8172 Dronabinol 10 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0527-1450 Dronabinol 2.5 mg Oral Capsule by Lannett Company, Inc.
  • 0527-1451 Dronabinol 5 mg Oral Capsule by Lannett Company, Inc.
  • 0527-1452 Dronabinol 10 mg Oral Capsule by Lannett Company, Inc.
  • 0527-4125 Dronabinol 2.5 mg Oral Capsule by Lannett Company, Inc.
  • 0591-3591 Dronabinol 2.5 mg Oral Capsule by Watson Laboratories, Inc.
  • 0591-3592 Dronabinol 5 mg Oral Capsule by Watson Laboratories, Inc.
  • 0591-3593 Dronabinol 10 mg Oral Capsule by Watson Laboratories, Inc.
  • 17478-761 Dronabinol 2.5 mg Oral Capsule by Akorn, Inc.
  • 17478-762 Dronabinol 5 mg Oral Capsule by Akorn, Inc.
  • 17478-763 Dronabinol 10 mg Oral Capsule by Akorn, Inc.
  • 31722-960 Dronabinol 2.5 mg Oral Capsule by Camber Pharmaceuticals Inc
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NDC QR Code

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