Prescription drug · ANDA
Buprenorphine NDC 58118-4459
Buprenorphine hydrochloride 2 mg/1 · Tablet · Sublingual · Clinical Solutions Wholesale, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58118-4459-8 | 5811844590858118445908 | 30 TABLET in 1 BLISTER PACK (58118-4459-8)Marketed from Feb 17, 2025 |
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
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Clinical Solutions Wholesale, LLCNDC labeler code 58118
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201760
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 58118-4459_2e5a8bb5-e89c-7e3e-e063-6294a90a6b18SPL ID 2e5a8bb5-e89c-7e3e-e063-6294a90a6b18SPL set ID 9d976ee7-9509-49da-89fd-48d7e712697bRxCUI 351264UNII 56W8MW3EN1
- 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
N458118445908followed by a unit qualifier and the quantityPackage 58118-4459-08. 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 tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (1) Buprenorphine sublingual tablet 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 58118-4459
- What is NDC 58118-4459?
- 58118-4459 is the product NDC for Buprenorphine, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Clinical Solutions Wholesale, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buprenorphine.
- What is the active ingredient?
- Buprenorphine hydrochloride.
- Who is the labeler?
- Clinical Solutions Wholesale, LLC, NDC labeler code 58118. 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?
- 53 other product NDCs are listed under this name. See all Buprenorphine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Buprenorphine 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 | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-082 | 87441-0082-01 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-011 | 87441-0011-01 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | AvPAK | 50268-128 | 50268-0128-15 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | AvPAK | 50268-129 | 50268-0129-15 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1521 | 03215-1521-04 |
| Buprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1522 | 03215-1522-04 |
| Buprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1523 | 03215-1523-04 |
| Buprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1524 | 03215-1524-04 |
| Buprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1525 | 03215-1525-04 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-372 | 50742-0372-04 |
Other NDCs under ANDA 201760
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 2 mg/1 | TabletSublingual | AvPAK | 50268-128 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | AvPAK | 50268-129 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-0460 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Sun Pharmaceutical Industries, Inc. | 62756-459 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Sun Pharmaceutical Industries, Inc. | 62756-460 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Redpharm Drug | 67296-2173 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-3152 |
| Buprenorphine Sublingual | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Direct_rx | 72189-579 |