NDC codes

FDA NDC Directory
Product NDC (as listed)31722-480Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0480Add 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 NDC11-digit (billing)PackageCopy
31722-480-303172204803030 POUCH in 1 CARTON (31722-480-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-480-31)Marketed from May 1, 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 and Naloxone
Generic name (nonproprietary)
buprenorphine and naloxone
Active ingredients
Buprenorphine hydrochloride4 mg/1Naloxone hydrochloride1 mg/1
Dosage form
Film, Soluble
Route
Buccal, Sublingual
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 219850
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 31722-480_fc47f8e4-395a-4030-b9fb-71ba779479bfSPL ID fc47f8e4-395a-4030-b9fb-71ba779479bfSPL set ID 221195e4-de08-414c-af08-a611a74789deRxCUI 1010600, 1010604, 1307056, 1307061UNII 56W8MW3EN1, F850569PQR
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. Buccal, Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N431722048030 followed by a unit qualifier and the quantity

Package 31722-0480-30. 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 and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual film 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 219850

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

FDA NDC Directory listings under ANDA 219850
ProductStrengthForm · routeLabelerProduct NDC
Buprenorphine and NaloxoneBuprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-479
Buprenorphine and NaloxoneBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-481
Buprenorphine and NaloxoneBuprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-482

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