43063-892 : Phendimetrazine Tartrate 105 mg Oral Capsule, Extended Release


NDC43063-892
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Phendimetrazine Tartrate
Dosage Form: Oral Capsule, Extended Release
Application #: NDA018074
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: E5254
Shapes:  Capsule
Colors:  Brown
Size (mm): 19
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.

E5254: (0185-5254) Phendimetrazine Tartrate 105 mg Oral Capsule, Extended Release by Pd-rx Pharmaceuticals, Inc.
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:

  • 43063-892-14: 14 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43063‑892‑14)
  • 43063-892-30: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43063‑892‑30)

Active Ingredients:

  • Phendimetrazine Tartrate

Dosage Strength:

  • 105 mg

Inactive Ingredients:

  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Gelatin, Unspecified
  • Povidone, Unspecified
  • Silicon Dioxide
  • Sodium Lauryl Sulfate
  • Starch, Corn
  • Sucrose
  • Talc
  • Shellac /

Pharmaceutical Classes:

  • Appetite Suppression [PE]
  • Increased Sympathetic Activity [PE]
  • Sympathomimetic Amine Anorectic [EPC]

Related Products:

Based on records with the same trade name.
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  • 10544-041 Phendimetrazine Tartrate 35 mg Oral Tablet by Blenheim Pharmacal, Inc.
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  • 12634-910 Phendimetrazine 105 mg 24 Hr Extended Release Capsule by Apotheca, Inc.
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  • 17224-500 Phendimetrazine Tartrate 35 mg Oral Tablet by Calvin, Scott and Company, Incorporated
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NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.