Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate NDC 87441-002

NDC codes

FDA NDC Directory

Product NDC (as listed)87441-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width87441-0002Add 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
87441-002-01	87441000201	30 TABLET in 1 BLISTER PACK (87441-002-01)Marketed from Apr 13, 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 and Naloxone Hydrochloride Dihydrate
Generic name (nonproprietary): buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Active ingredients: Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride dihydrate — 2 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Unit Dose Solutions, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207000
Marketing start: Apr 13, 2026
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 87441-002_4f978840-908f-5b24-e063-6294a90a6a29SPL ID 4f978840-908f-5b24-e063-6294a90a6a29SPL set ID 4f979409-f9a2-d3a2-e063-6394a90accd0RxCUI 351266, 351267UNII 56W8MW3EN1, 5Q187997EE
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

N487441000201 followed by a unit qualifier and the quantity

Package 87441-0002-01. 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 Apr 16, 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 contain 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.

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