NDC codes

FDA NDC Directory
Product NDC (as listed)0406-7012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-7012Add 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
0406-7012-03004067012030040670120330 TABLET in 1 BOTTLE (0406-7012-03)Marketed from Jan 19, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 HCl
Generic name (nonproprietary)
buprenorphine hcl
Active ingredients
Buprenorphine hydrochloride — 2 mg/1
Dosage form
Tablet
Route
Sublingual
Labeler
SpecGx LLCNDC labeler code 0406
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218473
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 0406-7012_d58166b1-982f-4402-af7a-a4afbcbf2e0fSPL ID d58166b1-982f-4402-af7a-a4afbcbf2e0fSPL set ID b60d514d-a88a-4fa2-a5b0-30ac29e04973RxCUI 351264, 351265UNII 56W8MW3EN1
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

N400406701203 followed by a unit qualifier and the quantity

Package 00406-7012-03. 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 are indicated for the treatment of opioid dependence and are 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 0406-7012

What is NDC 0406-7012?
0406-7012 is the product NDC for Buprenorphine HCl, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by SpecGx LLC. 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?
SpecGx LLC, NDC labeler code 0406. 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 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 2 mg/1TabletSublingualRedpharm Drug67296-212367296-2123-03
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualBryant Ranch Prepack71335-116371335-1163-0071335-1163-0171335-1163-02+7 more

Other NDCs under ANDA 218473

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

FDA NDC Directory listings under ANDA 218473
ProductStrengthForm · routeLabelerProduct NDC
Buprenorphine HClBuprenorphine hydrochloride 8 mg/1TabletSublingualSpecGx LLC0406-7018

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