NDC 60505-7053

Buprenorphine and Naloxone

Buprenorphine And Naloxone

Buprenorphine and Naloxone is a Buccal; Sublingual Film in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.

Product ID60505-7053_4bd20211-c9d7-e7db-2421-3422bf7df2a3
NDC60505-7053
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormFilm
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2022-06-03
Marketing CategoryANDA /
Application NumberANDA212756
Labeler NameApotex Corp.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 60505-7053-5

30 POUCH in 1 CARTON (60505-7053-5) > 1 FILM in 1 POUCH (60505-7053-0)
Marketing Start Date2022-06-03
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Buprenorphine and Naloxone" or generic name "Buprenorphine And Naloxone"

NDCBrand NameGeneric Name
0228-3154Buprenorphine and NaloxoneBuprenorphine and Naloxone
0228-3155Buprenorphine and NaloxoneBuprenorphine and Naloxone
0378-8765Buprenorphine and NaloxoneBuprenorphine and Naloxone
0378-8766Buprenorphine and NaloxoneBuprenorphine and Naloxone
0378-8767Buprenorphine and Naloxonebuprenorphine and naloxone
0378-8768Buprenorphine and Naloxonebuprenorphine and naloxone
0781-7216BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
0781-7249BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
0781-7227BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
0781-7238BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
43598-579Buprenorphine and NaloxoneBuprenorphine and Naloxone
43598-580Buprenorphine and NaloxoneBuprenorphine and Naloxone
43598-582Buprenorphine and NaloxoneBuprenorphine and Naloxone
43598-581Buprenorphine and NaloxoneBuprenorphine and Naloxone
50383-294Buprenorphine and NaloxoneBuprenorphine and Naloxone
50383-287Buprenorphine and NaloxoneBuprenorphine and Naloxone
53217-138Buprenorphine and NaloxoneBuprenorphine and Naloxone
60429-587Buprenorphine and NaloxoneBuprenorphine and Naloxone
60429-586Buprenorphine and NaloxoneBuprenorphine and Naloxone
62175-452Buprenorphine and NaloxoneBuprenorphine and Naloxone
62756-969Buprenorphine and NaloxoneBuprenorphine and Naloxone
62175-458Buprenorphine and NaloxoneBuprenorphine and Naloxone
62756-970Buprenorphine and NaloxoneBuprenorphine and Naloxone
63629-7270Buprenorphine and NaloxoneBuprenorphine and Naloxone
70518-2327Buprenorphine and NaloxoneBuprenorphine and Naloxone
70518-2311Buprenorphine and NaloxoneBuprenorphine and Naloxone
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
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