0904-6597 : Dronabinol 2.5 mg Oral Capsule


NDC: 0904-6597
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;867
Shapes:  Capsule
Colors:  White
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 867: (68084-174) Dronabinol 2.5 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:

  • 0904-6597-61: 100 BLISTER PACK IN 1 CARTON (0904‑6597‑61) > 1 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Dronabinol

Dosage Strength:

  • 2.5 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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  • 0904-7144 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.
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  • 17478-762 Dronabinol 5 mg Oral Capsule by Akorn, Inc.
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NDC QR Code

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