NDC codes

FDA NDC Directory
Product NDC (as listed)62175-452Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62175-0452Add 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
62175-452-32621750452326217504523230 TABLET in 1 BOTTLE (62175-452-32)Marketed from Sep 19, 2016

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 — 2 mg/1Naloxone — .5 mg/1
Dosage form
Tablet
Route
Sublingual
Labeler
Lannett Company, Inc.NDC labeler code 62175
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205022
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 62175-452_2f25fc02-629e-4539-82b9-f22f6937d72eSPL ID 2f25fc02-629e-4539-82b9-f22f6937d72eSPL set ID 14eaa94a-cc8a-4e1e-8cfb-5c976c96c606RxCUI 351266, 351267UNII 40D3SCR4GZ, 36B82AMQ7N
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

N462175045232 followed by a unit qualifier and the quantity

Package 62175-0452-32. 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 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 tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual tablet 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 62175-452

What is NDC 62175-452?
62175-452 is the product NDC for Buprenorphine and Naloxone, Buprenorphine 2 mg/1; Naloxone .5 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Buprenorphine and Naloxone.
What is the active ingredient?
Buprenorphine, Naloxone.
Who is the labeler?
Lannett Company, Inc., NDC labeler code 62175. 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 and Naloxone?
50 other product NDCs are listed under this name. See all Buprenorphine and Naloxone 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 Buprenorphine and Naloxone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Buprenorphine And NaloxoneBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1TabletSublingualAscend Laboratories, LLC67877-60667877-0606-3067877-0606-8467877-0606-90
Buprenorphine And NaloxoneBuprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1TabletSublingualAscend Laboratories, LLC67877-60767877-0607-3067877-0607-8467877-0607-90
Buprenorphine and NaloxoneBuprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-47931722-0479-30
Buprenorphine and NaloxoneBuprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-48031722-0480-30
Buprenorphine and NaloxoneBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-48131722-0481-30
Buprenorphine and NaloxoneBuprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1Film, SolubleBuccal, SublingualCamber Pharmaceuticals, Inc.31722-48231722-0482-30
Buprenorphine and NaloxoneBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1TabletSublingualUnit Dose Solutions, Inc.87441-00187441-0001-01
Buprenorphine and NaloxoneBuprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1TabletSublingualCamber Pharmaceuticals, Inc.31722-85031722-0850-30
Buprenorphine and NaloxoneBuprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1TabletSublingualCamber Pharmaceuticals, Inc.31722-85131722-0851-30
Buprenorphine and NaloxoneBuprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1FilmBuccal, SublingualAveva Drug Delivery Systems Inc.3215-652103215-6521-30

All 51 Buprenorphine and Naloxone NDCs

Other NDCs under ANDA 205022

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

FDA NDC Directory listings under ANDA 205022
ProductStrengthForm · routeLabelerProduct NDC
Buprenorphine and NaloxoneBuprenorphine 8 mg/1; Naloxone 2 mg/1TabletSublingualLannett Company, Inc.62175-458
Buprenorphine and NaloxoneBuprenorphine 2 mg/1; Naloxone .5 mg/1TabletSublingualBryant Ranch Prepack71335-1296
Buprenorphine and NaloxoneBuprenorphine 8 mg/1; Naloxone 2 mg/1TabletSublingualBryant Ranch Prepack71335-1378

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