43598-579 : Buprenorphine and Naloxone Buccal; Sublingual Film, Soluble


NDC43598-579
Labeler: Dr.reddys Laboratories Inc
Product Type: Human Prescription Drug
Drug Name:  Buprenorphine and Naloxone
Dosage Form: Buccal; Sublingual Film, Soluble
Application #: ANDA205299
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.

NDC Package Codes:

  • 43598-579-30: 30 POUCH IN 1 CARTON (43598‑579‑30) > 1 FILM, SOLUBLE IN 1 POUCH (43598‑579‑01)

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone

Dosage Strength:

  • 2 mg
  • .5 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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
  • 0093-5720 Buprenorphine and Naloxone Sublingual Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5721 Buprenorphine and Naloxone Sublingual Tablet by Teva Pharmaceuticals USA Inc
  • 0121-1018 Buprenorphine and Naloxone Sublingual Tablet by Pai Holdings, LLC Dba Pharmaceutical Associates, Inc. and Dba Pai Pharma
  • 0121-2036 Buprenorphine and Naloxone Sublingual Tablet by Pai Holdings, LLC Dba Pharmaceutical Associates, Inc. and Dba Pai Pharma
  • 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
  • 24555-0970 Buprenorphine and Naloxone Sublingual Tablet by Correct Rx Pharmacy Services, 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.
  • 50383-287 Buprenorphine and Naloxone Sublingual Tablet by Hi-tech Pharmacal Co., Inc.
  • 50383-294 Buprenorphine and Naloxone Sublingual Tablet by Hi-tech Pharmacal Co., Inc.
  • More related products ...

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