33261-354 : Diethylpropion Hydrochlorideer 75 mg/1 Oral Tablet, Extended Release

Labeler: Aidarex Pharmaceuticals LLC
Product Type: Human Prescription Drug
Drug Name:  Diethylpropion Hydrochlorideer ER
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA091680
Rev. Date: 
CSA Schedule: CIV (US) [1]

[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.


Markings: LCI;1477
Shapes:  Oval
Colors:  White
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.

NDC Package Codes:

  • 33261-354-07: 7 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (33261‑354‑07)
  • 33261-354-14: 14 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (33261‑354‑14)
  • 33261-354-28: 28 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (33261‑354‑28)
  • 33261-354-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (33261‑354‑30)

Active Ingredients:

  • Diethylpropion Hydrochloride

Dosage Strength:

  • 75 mg

Inactive Ingredients:

  • Mannitol
  • Carbomer Homopolymer Type a (Allyl Pentaerythritol Crosslinked)
  • Tartaric Acid
  • Hypromellose Acetate Succinate 06081224 (3 Mm2/S)
  • Povidone K30
  • Magnesium Stearate

Pharmaceutical Classes:

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


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