Prescription drug · ANDA
Buprenorphine HCl NDC 0406-7018
Buprenorphine hydrochloride 8 mg/1 · Tablet · Sublingual · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-7018-03 | 0040670180300406701803 | 30 TABLET in 1 BOTTLE (0406-7018-03)Marketed from Jan 19, 2026 |
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 HCl
- Generic name (nonproprietary)
- buprenorphine hcl
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218473
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0406-7018_d58166b1-982f-4402-af7a-a4afbcbf2e0fSPL ID d58166b1-982f-4402-af7a-a4afbcbf2e0fSPL set ID b60d514d-a88a-4fa2-a5b0-30ac29e04973RxCUI 351264, 351265UNII 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
N400406701803followed by a unit qualifier and the quantityPackage 00406-7018-03. 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 are indicated for the treatment of opioid dependence and are 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 0406-7018
- What is NDC 0406-7018?
- 0406-7018 is the product NDC for Buprenorphine HCl, Buprenorphine hydrochloride 8 mg/1 tablet, listed with the FDA by SpecGx LLC. 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?
- SpecGx LLC, NDC labeler code 0406. 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 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 2 mg/1 | TabletSublingual | Redpharm Drug | 67296-2123 | 67296-2123-03 |
| 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 218473
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 | SpecGx LLC | 0406-7012 |