Prescription drug · ANDA
Buprenorphine HCl NDC 67296-2123
Buprenorphine hydrochloride 2 mg/1 · Tablet · Sublingual · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2123-3 | 6729621230367296212303 | 30 TABLET in 1 BOTTLE (67296-2123-3)Marketed from Oct 8, 2009 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCl
- Generic name (nonproprietary)
- buprenorphine hcl
- Active ingredients
- Buprenorphine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Redpharm DrugNDC labeler code 67296
- 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 67296-2123_4698a89b-6565-4e29-e063-6394a90aaf22SPL ID 4698a89b-6565-4e29-e063-6394a90aaf22SPL set ID 301eaed5-8499-ad95-e063-6294a90a58f5RxCUI 351264UNII 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
N467296212303followed by a unit qualifier and the quantityPackage 67296-2123-03. 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.
About NDC 67296-2123
- What is NDC 67296-2123?
- 67296-2123 is the product NDC for Buprenorphine HCl, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buprenorphine HCl.
- What is the active ingredient?
- Buprenorphine hydrochloride.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Buprenorphine HCl?
- 9 other product NDCs are listed under this name. See all Buprenorphine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Buprenorphine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | SpecGx LLC | 0406-7012 | 00406-7012-03 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | SpecGx LLC | 0406-7018 | 00406-7018-03 |
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Camber Pharmaceuticals, Inc. | 31722-870 | 31722-0870-30 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Camber Pharmaceuticals, Inc. | 31722-871 | 31722-0871-30 |
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2226 | 70518-2226-0070518-2226-05 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2014 | 70518-2014-0070518-2014-02 |
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-0176 | 58118-0176-08 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-0177 | 58118-0177-08 |
| Buprenorphine HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1163 | 71335-1163-0071335-1163-0171335-1163-02+7 more |
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 | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0177 |
| 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 HCl | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2014 |
| Buprenorphine HCl | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-2226 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7154 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0176 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7155 |
| 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 |