0378-1063 : Guanfacine Hydrochloride 3 mg Oral Tablet, Film Coated, Extended Release


NDC0378-1063
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Guanfacine Hydrochloride
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA202578
Rev. Date: 


Appearance:


Markings: M;GH;3
Shapes:  Round
Colors:  Green
Size (mm): 9
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:

  • 0378-1063-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑1063‑01)
  • 0378-1063-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑1063‑05)
  • 0378-1063-93: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑1063‑93)

Active Ingredients:

  • Guanfacine Hydrochloride

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Ammonia
  • Silicon Dioxide
  • Crospovidone
  • D&c Yellow No. 10
  • Ethylcelluloses
  • Fd&c Blue No. 2
  • Glyceryl Dibehenate
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Medium-chain Triglycerides
  • Cellulose, Microcrystalline
  • Oleic Acid
  • Polyethylene Glycols
  • Povidones

Pharmaceutical Classes:

  • Adrenergic alpha2-Agonists [MoA]
  • Central alpha-2 Adrenergic Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-1061 Guanfacine Hydrochloride 1 mg Oral Tablet, Film Coated, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-1062 Guanfacine Hydrochloride 2 mg Oral Tablet, Film Coated, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-1065 Guanfacine Hydrochloride 4 mg Oral Tablet, Film Coated, Extended Release by Mylan Pharmaceuticals Inc.
  • 0904-6183 Guanfacine 1 mg (Guanfacine Hydrochloride 1.15 mg) Oral Tablet by Major Pharmaceuticals
  • 0904-6184 Guanfacine 2 mg (Guanfacine Hydrochloride 2.3 mg) Oral Tablet by Major Pharmaceuticals
  • 17856-0711 Guanfacine Hydrochloride 1 mg Oral Tablet by Atlantic Biologicals Corps
  • 24979-198 Guanfacine Hydrochloride 1 mg Oral Tablet by Twi Pharmaceuticals, Inc.
  • 24979-199 Guanfacine Hydrochloride 2 mg Oral Tablet by Twi Pharmaceuticals, Inc.
  • 29300-458 Guanfacine Hydrochloride Hydrochloride 1 mg Oral Tablet by Unichem Pharmaceuticals (Usa), Inc.
  • 29300-459 Guanfacine Hydrochloride Hydrochloride 2 mg Oral Tablet by Unichem Pharmaceuticals (Usa), Inc.
  • 42291-310 Guanfacine 1 mg (Guanfacine Hydrochloride 1.15 mg) Oral Tablet by Avkare, Inc.
  • 42291-311 Guanfacine 2 mg (Guanfacine Hydrochloride 2.3 mg) Oral Tablet by Avkare, Inc.
  • 43826-044 Guanfacine Hydrochloride 1 mg Oral Tablet by Bora Pharmaceutical Laboratories Inc.
  • 43826-045 Guanfacine Hydrochloride 2 mg Oral Tablet by Bora Pharmaceutical Laboratories Inc.
  • 50090-4119 Guanfacine Hydrochloride 1 mg Oral Tablet by A-s Medication Solutions
  • 50090-6073 Guanfacine Hydrochloride 1 mg Oral Tablet by A-s Medication Solutions
  • 50268-373 Guanfacine Hydrochloride 1 mg Oral Tablet by Avpak
  • 50268-374 Guanfacine Hydrochloride 2 mg Oral Tablet by Avpak
  • 53746-711 Guanfacine Hydrochloride 1 mg Oral Tablet by Amneal Pharmaceuticals of New York LLC
  • 53746-713 Guanfacine Hydrochloride 2 mg Oral Tablet by Amneal Pharmaceuticals of New York LLC
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NDC QR Code

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