Prescription drug · ANDA
buprenorphine hydrochloride NDC 70518-4571
Buprenorphine hydrochloride 8 mg/1 · Tablet · Sublingual · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4571-0 | 70518457100 | 30 POUCH in 1 BOX (70518-4571-0) / 1 TABLET in 1 POUCH (70518-4571-1)Marketed from Feb 10, 2026 | |
| 70518-4571-2 | 70518457102 | 50 POUCH in 1 BOX (70518-4571-2) / 1 TABLET in 1 POUCH (70518-4571-1)Marketed from Jul 7, 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
- Generic name (nonproprietary)
- buprenorphine hydrochloride
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090622
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 70518-4571_560a405f-39ff-e178-e063-6394a90a5dbaSPL ID 560a405f-39ff-e178-e063-6394a90a5dbaSPL set ID 11686845-f5fd-4e96-8a4f-9b132bf48840RxCUI 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
N470518457100followed by a unit qualifier and the quantityPackage 70518-4571-00. 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 is indicated for the treatment of opioid dependence and is 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 contains 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 70518-4571
- What is NDC 70518-4571?
- 70518-4571 is the product NDC for buprenorphine hydrochloride, Buprenorphine hydrochloride 8 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- buprenorphine hydrochloride.
- What is the active ingredient?
- Buprenorphine hydrochloride.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 12 other product NDCs are listed under this name. See all buprenorphine hydrochloride 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 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 | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4570 | 70518-4570-00 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 12 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-510 | 72888-0510-0172888-0510-02 |
| Buprenorphine Hydrochloride | Buprenorphine hydrochloride .324 mg/mL | InjectionIntramuscular, Intravenous | Somerset Therapeutics, LLC | 70069-027 | 70069-0027-05 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | 0121-1019 | 00121-1019-30 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | 0121-2038 | 00121-2038-30 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-7559 | 50090-7559-00 |
| Buprenorphine Hydrochloride | Buprenorphine hydrochloride .324 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-179 | 42023-0179-05 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-182 | 72888-0182-3072888-0182-90 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-183 | 72888-0183-3072888-0183-90 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 4 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-509 | 72888-0509-0172888-0509-02 |
Other NDCs under ANDA 090622
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 hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | 0121-1019 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | 0121-2038 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-7559 |