50383-287 : Buprenorphine and Naloxone Sublingual Tablet


NDC50383-287
Labeler: Hi-tech Pharmacal Co., Inc.
Product Type: Human Prescription Drug
Drug Name:  Buprenorphine and Naloxone
Dosage Form: Sublingual Tablet
Application #: ANDA204431
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: N8;Up;Arrow
Shapes:  Round
Colors:  White
Size (mm): 11
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:

  • 50383-287-33: 30 TABLET IN 1 BLISTER PACK (50383‑287‑33)
  • 50383-287-93: 30 TABLET IN 1 BOTTLE, PLASTIC (50383‑287‑93)

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone Hydrochloride

Dosage Strength:

  • 8 mg
  • 2 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Mannitol
  • Starch, Corn
  • Povidone K30
  • Water
  • Anhydrous Citric Acid
  • Sodium Citrate
  • Sodium Stearyl Fumarate
  • Acesulfame Potassium

Pharmaceutical Classes:

  • Partial Opioid Agonists [MoA]
  • Partial Opioid Agonist [EPC]
  • Opioid Antagonist [EPC]
  • Opioid Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 50383-294 Buprenorphine and Naloxone Sublingual Tablet by Hi-tech Pharmacal Co., Inc.
  • 0093-5720 Buprenorphine and Naloxone Sublingual Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5721 Buprenorphine and Naloxone Sublingual Tablet by Teva Pharmaceuticals USA Inc
  • 0378-8765 Buprenorphine and Naloxone Buccal; Sublingual Film by Mylan Pharmaceuticals Inc.
  • 0378-8766 Buprenorphine and Naloxone Buccal; Sublingual Film by Mylan Pharmaceuticals Inc.
  • 0378-8767 Buprenorphine and Naloxone Buccal; Sublingual Film by Mylan Pharmaceuticals Inc.
  • 0378-8768 Buprenorphine and Naloxone Buccal; Sublingual Film by Mylan Pharmaceuticals Inc.
  • 0781-7216 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Sandoz Inc
  • 0781-7227 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Sandoz Inc
  • 0781-7238 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Sandoz Inc
  • 0781-7249 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Sandoz Inc
  • 42858-601 Buprenorphine and Naloxone Sublingual Tablet by Rhodes Parmaceuticals L.p.
  • 42858-602 Buprenorphine and Naloxone Sublingual Tablet by Rhodes Parmaceuticals L.p.
  • 43598-579 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Dr.reddys Laboratories Inc
  • 43598-580 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Dr.reddys Laboratories Inc
  • 43598-581 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Dr.reddys Laboratories Inc
  • 43598-582 Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble by Dr.reddys Laboratories Inc
  • 53217-138 Buprenorphine and Naloxone Sublingual Tablet by Aidarex Pharmaceuticals LLC
  • 60429-586 Buprenorphine and Naloxone Sublingual Tablet by Golden State Medical Supply, Inc.
  • 60429-587 Buprenorphine and Naloxone Sublingual Tablet by Golden State Medical Supply, Inc.
  • More related products ...

NDC QR Code

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