Buprenorphine and Naloxone NDC 0121-2036

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-2036Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-2036Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0121-2036-30	00121203630	30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30)Marketed from Sep 5, 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 and Naloxone
Generic name (nonproprietary): buprenorphine hydrochloride and naloxone hydrochloride
Active ingredients: Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride — 2 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204431
Marketing start: Sep 5, 2023
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 0121-2036_5c5bd328-aba7-4c89-9380-b7100d9bcf17SPL ID 5c5bd328-aba7-4c89-9380-b7100d9bcf17SPL set ID d5b011ef-f1be-47f2-8f8b-07553f36193cRxCUI 351266, 351267UNII 56W8MW3EN1, F850569PQRUPC 0301211018304, 0301212036307
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

N400121203630 followed by a unit qualifier and the quantity

Package 00121-2036-30. 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 Feb 28, 2026.

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 that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablets contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ( 1 ). Buprenorphine and naloxone 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204431

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204431
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	TabletSublingual	PAI Holdings, LLC dba PAI Pharma	0121-1018