What is NDC 54123-929?

54123-929 is the product NDC for Zubsolv, Buprenorphine hydrochloride 2.9 mg/1; Naloxone hydrochloride .71 mg/1 tablet, orally disintegrating, listed with the FDA by Orexo US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Zubsolv (Buprenorphine hydrochloride and naloxone hydrochloride).

What is the active ingredient?

Buprenorphine hydrochloride, Naloxone hydrochloride.

Orexo US, Inc., NDC labeler code 54123. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zubsolv?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zubsolv NDC 54123-929 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54123-929Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54123-0929Add 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 NDC	11-digit (billing)	Package	Copy
54123-929-30	54123092930	3 BLISTER PACK in 1 CARTON (54123-929-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jul 4, 2013

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): Zubsolv
Generic name (nonproprietary): buprenorphine hydrochloride and naloxone hydrochloride
Active ingredients: Buprenorphine hydrochloride — 2.9 mg/1Naloxone hydrochloride — .71 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Sublingual
Labeler: Orexo US, Inc.NDC labeler code 54123
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204242
Marketing start: Jul 4, 2013
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 54123-929_8c67e97f-118f-4226-972a-a9031ef6f5ceSPL ID 8c67e97f-118f-4226-972a-a9031ef6f5ceSPL set ID 5f5cfcfe-d52b-49e6-8fe4-550477332dd2RxCUI 1431076, 1431083, 1431102, 1431104, 1597568, 1597570, 1597573, 1597575, 1666338, 1666385, 1864412, 1864414UNII F850569PQR, 56W8MW3EN1
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

N454123092930 followed by a unit qualifier and the quantity

Package 54123-0929-30. 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 Dec 27, 2025.

Indications (excerpt from the label)

ZUBSOLV is indicated for treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support. ZUBSOLV contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) ZUBSOLV 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 54123-929

What is NDC 54123-929?: 54123-929 is the product NDC for Zubsolv, Buprenorphine hydrochloride 2.9 mg/1; Naloxone hydrochloride .71 mg/1 tablet, orally disintegrating, listed with the FDA by Orexo US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zubsolv (Buprenorphine hydrochloride and naloxone hydrochloride).
What is the active ingredient?: Buprenorphine hydrochloride, Naloxone hydrochloride.
Who is the labeler?: Orexo US, Inc., NDC labeler code 54123. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zubsolv?: 11 other product NDCs are listed under this name. See all Zubsolv 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 Zubsolv NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 5.7 mg/1; Naloxone hydrochloride 1.4 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-204	82111-0204-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride .7 mg/1; Naloxone hydrochloride .18 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-201	82111-0201-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 1.4 mg/1; Naloxone hydrochloride .36 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-202	82111-0202-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 2.9 mg/1; Naloxone hydrochloride .71 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-203	82111-0203-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 8.6 mg/1; Naloxone hydrochloride 2.1 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-205	82111-0205-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 11.4 mg/1; Naloxone hydrochloride 2.9 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-206	82111-0206-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 11.4 mg/1; Naloxone hydrochloride 2.9 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-114	54123-0114-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 8.6 mg/1; Naloxone hydrochloride 2.1 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-986	54123-0986-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride .7 mg/1; Naloxone hydrochloride .18 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-907	54123-0907-30
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 1.4 mg/1; Naloxone hydrochloride .36 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-914	54123-0914-30

All 12 Zubsolv NDCs

Other NDCs under NDA 204242

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

FDA NDC Directory listings under NDA 204242
Product	Strength	Form · route	Labeler	Product NDC
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 11.4 mg/1; Naloxone hydrochloride 2.9 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-114
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride .7 mg/1; Naloxone hydrochloride .18 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-907
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 1.4 mg/1; Naloxone hydrochloride .36 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-914
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 5.7 mg/1; Naloxone hydrochloride 1.4 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-957
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 8.6 mg/1; Naloxone hydrochloride 2.1 mg/1	Tablet, Orally disintegratingSublingual	Orexo US, Inc.	54123-986
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 5.7 mg/1; Naloxone hydrochloride 1.4 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-204
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride .7 mg/1; Naloxone hydrochloride .18 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-201
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 1.4 mg/1; Naloxone hydrochloride .36 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-202
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 2.9 mg/1; Naloxone hydrochloride .71 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-203
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 8.6 mg/1; Naloxone hydrochloride 2.1 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-205
Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride	Buprenorphine hydrochloride 11.4 mg/1; Naloxone hydrochloride 2.9 mg/1	Tablet, Orally disintegratingSublingual	Edenbridge Pharmaceuticals LLC.	82111-206