Buprenorphine and Naloxone Sublingual Film is a Buccal; Sublingual Film in the Human Prescription Drug category. It is labeled and distributed by Almatica Pharma Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.
| Product ID | 52427-694_38c4d210-ed50-b924-94da-7067eda6fa9f |
| NDC | 52427-694 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Buprenorphine and Naloxone Sublingual Film |
| Generic Name | Buprenorphine And Naloxone |
| Dosage Form | Film |
| Route of Administration | BUCCAL; SUBLINGUAL |
| Marketing Start Date | 2019-02-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205954 |
| Labeler Name | Almatica Pharma Inc. |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
| Active Ingredient Strength | 4 mg/1; mg/1 |
| Pharm Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-02-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA205954 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-11 |
| Marketing Category | ANDA |
| Application Number | ANDA205954 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-11 |
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 4 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 47781-357 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 47781-355 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 47781-358 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 47781-356 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 52427-692 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 52427-694 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 52427-698 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 52427-712 | Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Film |
| 0228-3154 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
| 0228-3155 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
| 0378-8765 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
| 0378-8766 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
| 0378-8767 | Buprenorphine and Naloxone | buprenorphine and naloxone |
| 0378-8768 | Buprenorphine and Naloxone | buprenorphine and naloxone |
| 0406-1923 | Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone |
| 0406-1924 | Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone |
| 42291-174 | Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone |