Prescription drug · ANDA
Buprenorphine NDC 0054-0177
Buprenorphine hydrochloride 8 mg/1 · Tablet · Sublingual · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0177-13 | 00054017713 | 30 TABLET in 1 BOTTLE (0054-0177-13)Marketed from Oct 8, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Buprenorphine
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078633
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0054-0177_e59c3c4f-a9cc-412b-b001-b9e430f537c5SPL ID e59c3c4f-a9cc-412b-b001-b9e430f537c5SPL set ID 1bf8b35a-b769-465c-a2f8-099868dfcd2fRxCUI 351264, 351265UNII 56W8MW3EN1UPC 0300540176136
- Pharmacologic class
- Partial Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400054017713followed by a unit qualifier and the quantityPackage 00054-0177-13. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine Sublingual Tablets contain buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. ( 1 ) Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078633
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Redpharm Drug | 67296-2123 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2014 |
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2226 |
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-0176 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-0177 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0176 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1163 |
| Buprenorphine Sublingual C-III | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Direct_Rx | 72189-580 |
| Buprenorphine Sublingual C-III | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Direct_Rx | 72189-582 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7154 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7155 |