Prescription drug · ANDA
buprenorphine hydrochloride and naloxone hydrochloride dihydrate NDC 58118-1189
Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 · Tablet · Sublingual · Clinical Solutions Wholesale, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58118-1189-8 | 5811811890858118118908 | 30 TABLET in 1 BLISTER PACK (58118-1189-8)Marketed from Mar 4, 2026 |
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 hydrochloride and naloxone hydrochloride dihydrate
- Generic name (nonproprietary)
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride dihydrate — 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 203326
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 58118-1189_4c5e6bea-03d2-6813-e063-6294a90aa347SPL ID 4c5e6bea-03d2-6813-e063-6294a90aa347SPL set ID 99a5b62f-bc08-44f4-abb8-300520d2162aRxCUI 351266, 351267UNII 5Q187997EE, 56W8MW3EN1
- Pharmacologic class
- Opioid Antagonist; 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
N458118118908followed by a unit qualifier and the quantityPackage 58118-1189-08. 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 and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ( ) Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( )
Excerpt only. Read the full label for complete information.
About NDC 58118-1189
- What is NDC 58118-1189?
- 58118-1189 is the product NDC for buprenorphine hydrochloride and naloxone hydrochloride dihydrate, Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 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 hydrochloride and naloxone hydrochloride dihydrate.
- What is the active ingredient?
- Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate.
- 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 hydrochloride and naloxone hydrochloride dihydrate?
- 22 other product NDCs are listed under this name. See all buprenorphine hydrochloride and naloxone hydrochloride dihydrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other buprenorphine hydrochloride and naloxone hydrochloride dihydrate 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 Hydrochloride and Naloxone Hydrochloride Dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-002 | 87441-0002-01 |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-003 | 87441-0003-01 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-3862 | 70518-3862-00 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-3844 | 70518-3844-00 |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1858 | 71335-1858-0071335-1858-0171335-1858-02+7 more |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Asclemed USA, Inc. | 76420-534 | 76420-0534-30 |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Accord Healthcare, Inc | 16729-549 | 16729-0549-10 |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Accord Healthcare, Inc | 16729-550 | 16729-0550-10 |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-0549 | 58118-0549-08 |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Redpharm Drug | 67296-2191 | 67296-2191-0167296-2191-06 |
All 23 buprenorphine hydrochloride and naloxone hydrochloride dihydrate NDCs
Other NDCs under ANDA 203326
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 and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0188 |
| buprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0189 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7009 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7010 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Naloxone hydrochloride dihydrate .5 mg/1; Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 51407-948 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 51407-949 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-1188 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-3844 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-3862 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1653 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1720 |