Prescription drug · ANDA
buprenorphine hydrochloride NDC 0121-2038
Buprenorphine hydrochloride 8 mg/1 · Tablet · Sublingual · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-2038-30 | 0012120383000121203830 | 30 TABLET in 1 BOTTLE (0121-2038-30)Marketed from Oct 12, 2023 |
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 hydrochloride
- Generic name (nonproprietary)
- buprenorphine hydrochloride
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- 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 0121-2038_2b5cbeb4-82cc-4f47-a277-9b16e5dbc150SPL ID 2b5cbeb4-82cc-4f47-a277-9b16e5dbc150SPL set ID 442831cf-9636-433a-9a12-e9a8cd31f72aRxCUI 351264, 351265UNII 56W8MW3EN1UPC 0301211019301, 0301212038301
- 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
N400121203830followed by a unit qualifier and the quantityPackage 00121-2038-30. 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 0121-2038
- What is NDC 0121-2038?
- 0121-2038 is the product NDC for buprenorphine hydrochloride, Buprenorphine hydrochloride 8 mg/1 tablet, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, 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?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 8 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4571 | 70518-4571-0070518-4571-02 |
| 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 | 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 | A-S Medication Solutions | 50090-7559 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4571 |