What is NDC 58118-0176?

58118-0176 is the product NDC for Buprenorphine HCl, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Clinical Solutions Wholesale, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Clinical Solutions Wholesale, LLC, NDC labeler code 58118. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buprenorphine HCl NDC 58118-0176 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58118-0176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58118-0176Add 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
58118-0176-8	5811801760858118017608	30 TABLET in 1 BLISTER PACK (58118-0176-8)Marketed from Oct 15, 2018

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: Clinical Solutions Wholesale, LLCNDC labeler code 58118
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078633
Marketing start: Oct 8, 2009
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 58118-0176_0e76c642-8fc8-c0b6-e063-6394a90a413eSPL ID 0e76c642-8fc8-c0b6-e063-6394a90a413eSPL set ID 3a7418a2-bd6e-4082-b0fe-a5498e7b944aRxCUI 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

N458118017608 followed by a unit qualifier and the quantity

Package 58118-0176-08. 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 Jan 8, 2024.

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. 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 58118-0176

What is NDC 58118-0176?: 58118-0176 is the product NDC for Buprenorphine HCl, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Clinical Solutions Wholesale, 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?: Clinical Solutions Wholesale, LLC, NDC labeler code 58118. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	SpecGx LLC	0406-7012	00406-7012-03
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	SpecGx LLC	0406-7018	00406-7018-03
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-870	31722-0870-30
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-871	31722-0871-30
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-2226	70518-2226-0070518-2226-05
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-2014	70518-2014-0070518-2014-02
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Clinical Solutions Wholesale, LLC	58118-0177	58118-0177-08
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Redpharm Drug	67296-2123	67296-2123-03
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1163	71335-1163-0071335-1163-0171335-1163-02+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
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Hikma Pharmaceuticals USA Inc.	0054-0177
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1163
Buprenorphine Sublingual C-III	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Direct_Rx	72189-580
Buprenorphine Sublingual C-III	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Direct_Rx	72189-582
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-2014
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Redpharm Drug	67296-2123
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-2226
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Major Pharmaceuticals	0904-7154
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Hikma Pharmaceuticals USA Inc.	0054-0176
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Major Pharmaceuticals	0904-7155
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Clinical Solutions Wholesale, LLC	58118-0177