NDC codes

FDA NDC Directory
Product NDC (as listed)67296-2123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-2123Add 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
67296-2123-3672962123036729621230330 TABLET in 1 BOTTLE (67296-2123-3)Marketed from Oct 8, 2009

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)
Buprenorphine HCl
Generic name (nonproprietary)
buprenorphine hcl
Active ingredients
Buprenorphine hydrochloride — 2 mg/1
Dosage form
Tablet
Route
Sublingual
Labeler
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078633
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 67296-2123_4698a89b-6565-4e29-e063-6394a90aaf22SPL ID 4698a89b-6565-4e29-e063-6394a90aaf22SPL set ID 301eaed5-8499-ad95-e063-6294a90a58f5RxCUI 351264UNII 56W8MW3EN1UPC 0300540176136
Pharmacologic class
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

N467296212303 followed by a unit qualifier and the quantity

Package 67296-2123-03. 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)

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine Sublingual Tablets contain buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. ( 1 ) Buprenorphine 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)

About NDC 67296-2123

What is NDC 67296-2123?
67296-2123 is the product NDC for Buprenorphine HCl, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Buprenorphine HCl.
What is the active ingredient?
Buprenorphine hydrochloride.
Who is the labeler?
Redpharm Drug, NDC labeler code 67296. 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 HCl?
9 other product NDCs are listed under this name. See all Buprenorphine HCl 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 HCl NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Buprenorphine HClBuprenorphine hydrochloride 2 mg/1TabletSublingualSpecGx LLC0406-701200406-7012-03
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualSpecGx LLC0406-701800406-7018-03
Buprenorphine HClBuprenorphine hydrochloride 2 mg/1TabletSublingualCamber Pharmaceuticals, Inc.31722-87031722-0870-30
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualCamber Pharmaceuticals, Inc.31722-87131722-0871-30
Buprenorphine HClBuprenorphine hydrochloride 2 mg/1TabletSublingualREMEDYREPACK INC.70518-222670518-2226-0070518-2226-05
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualREMEDYREPACK INC.70518-201470518-2014-0070518-2014-02
Buprenorphine HClBuprenorphine hydrochloride 2 mg/1TabletSublingualClinical Solutions Wholesale, LLC58118-017658118-0176-08
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualClinical Solutions Wholesale, LLC58118-017758118-0177-08
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualBryant Ranch Prepack71335-116371335-1163-0071335-1163-0171335-1163-02+7 more

Other NDCs under ANDA 078633

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

FDA NDC Directory listings under ANDA 078633
ProductStrengthForm · routeLabelerProduct NDC
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualHikma Pharmaceuticals USA Inc.0054-0177
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualBryant Ranch Prepack71335-1163
Buprenorphine Sublingual C-IIIBuprenorphine hydrochloride 2 mg/1TabletSublingualDirect_Rx72189-580
Buprenorphine Sublingual C-IIIBuprenorphine hydrochloride 8 mg/1TabletSublingualDirect_Rx72189-582
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualREMEDYREPACK INC.70518-2014
Buprenorphine HClBuprenorphine hydrochloride 2 mg/1TabletSublingualREMEDYREPACK INC.70518-2226
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualMajor Pharmaceuticals0904-7154
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualHikma Pharmaceuticals USA Inc.0054-0176
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualMajor Pharmaceuticals0904-7155
Buprenorphine HClBuprenorphine hydrochloride 2 mg/1TabletSublingualClinical Solutions Wholesale, LLC58118-0176
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualClinical Solutions Wholesale, LLC58118-0177

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