NDC codes

FDA NDC Directory
Product NDC (as listed)12496-1202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width12496-1202Add 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
12496-1202-31249612020330 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1)Marketed from Sep 13, 2010

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Suboxone
Generic name (nonproprietary)
buprenorphine hydrochloride, naloxone hydrochloride
Active ingredients
Buprenorphine hydrochloride — 2 mg/1Naloxone hydrochloride — .5 mg/1
Dosage form
Film, Soluble
Route
Buccal, Sublingual
Labeler
INDIVIOR INC.NDC labeler code 12496
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022410
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 12496-1202_ad5a289a-6285-4b2d-b7ad-e4812169dd58SPL ID ad5a289a-6285-4b2d-b7ad-e4812169dd58SPL set ID 8a5edcf9-828c-4f97-b671-268ab13a8ecdRxCUI 1010600, 1010603, 1010604, 1010606, 1307056, 1307058, 1307061, 1307063UNII 56W8MW3EN1, F850569PQRUPC 0312496120835
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

N412496120203 followed by a unit qualifier and the quantity

Package 12496-1202-03. 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)

SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBOXONE® sublingual film contains buprenorphine, a partial‐opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) SUBOXONE 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)

About NDC 12496-1202

What is NDC 12496-1202?
12496-1202 is the product NDC for Suboxone, Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 film, soluble, listed with the FDA by INDIVIOR INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Suboxone (Buprenorphine hydrochloride, naloxone hydrochloride).
What is the active ingredient?
Buprenorphine hydrochloride, Naloxone hydrochloride.
Who is the labeler?
INDIVIOR INC., NDC labeler code 12496. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Suboxone?
3 other product NDCs are listed under this name. See all Suboxone NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Suboxone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Suboxonebuprenorphine hydrochloride, naloxone hydrochlorideBuprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1Film, SolubleBuccal, SublingualINDIVIOR INC.12496-120412496-1204-03
Suboxonebuprenorphine hydrochloride, naloxone hydrochlorideBuprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1Film, SolubleBuccal, SublingualINDIVIOR INC.12496-121212496-1212-03
Suboxonebuprenorphine hydrochloride, naloxone hydrochlorideBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1Film, SolubleBuccal, SublingualINDIVIOR INC.12496-120812496-1208-03

Other NDCs under NDA 022410

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

FDA NDC Directory listings under NDA 022410
ProductStrengthForm · routeLabelerProduct NDC
Suboxonebuprenorphine hydrochloride, naloxone hydrochlorideBuprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1Film, SolubleBuccal, SublingualINDIVIOR INC.12496-1204
Suboxonebuprenorphine hydrochloride, naloxone hydrochlorideBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1Film, SolubleBuccal, SublingualINDIVIOR INC.12496-1208
Suboxonebuprenorphine hydrochloride, naloxone hydrochlorideBuprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1Film, SolubleBuccal, SublingualINDIVIOR INC.12496-1212

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