Prescription drug · ANDA
buprenorphine hydrochloride NDC 72888-509
Buprenorphine hydrochloride 4 mg/1 · Tablet · Sublingual · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-509-01 | 72888050901 | 30 TABLET in 1 BOTTLE (72888-509-01)Marketed from Jul 10, 2026 | |
| 72888-509-02 | 72888050902 | 90 TABLET in 1 BOTTLE (72888-509-02)Marketed from Jul 10, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 hydrochloride
- Generic name (nonproprietary)
- buprenorphine hydrochloride
- Active ingredients
- Buprenorphine hydrochloride — 4 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Advagen Pharma Ltd
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090279
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72888-509_56cc7ad7-e846-8168-e063-6294a90a336dSPL ID 56cc7ad7-e846-8168-e063-6294a90a336dSPL set ID 699638dd-3a53-445f-a545-d0e6eabfe1c9RxCUI 351264, 351265, 2747481, 2747482UNII 56W8MW3EN1UPC 0372888510019, 0372888183909, 0372888182308, 0372888510026, 0372888183305, 0372888182902, 0372888509013, 0372888509020
- 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
N472888050901followed by a unit qualifier and the quantityPackage 72888-0509-01. 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 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 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.
Other NDCs under ANDA 090279
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 12 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-510 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4570 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-182 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-183 |