What is NDC 58118-0501?

58118-0501 is the product NDC for Buprenorphine, 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?

53 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buprenorphine NDC 58118-0501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58118-0501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58118-0501Add 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
58118-0501-8	5811805010858118050108	30 TABLET in 1 BLISTER PACK (58118-0501-8)Marketed from Oct 25, 2017

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
Generic name (nonproprietary): buprenorphine
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 207276
Marketing start: Oct 25, 2017
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 58118-0501_0e85a5c9-76a8-f621-e063-6394a90a8782SPL ID 0e85a5c9-76a8-f621-e063-6394a90a8782SPL set ID 325532f0-276f-4689-97d6-cda879b4c758RxCUI 351264UNII 56W8MW3EN1UPC 0358118050180
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

N458118050108 followed by a unit qualifier and the quantity

Package 58118-0501-08. 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 9, 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 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 58118-0501

What is NDC 58118-0501?: 58118-0501 is the product NDC for Buprenorphine, 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.
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?: 53 other product NDCs are listed under this name. See all Buprenorphine 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Unit Dose Solutions, Inc.	87441-082	87441-0082-01
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Unit Dose Solutions, Inc.	87441-011	87441-0011-01
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	AvPAK	50268-128	50268-0128-15
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	AvPAK	50268-129	50268-0129-15
Buprenorphine	Buprenorphine 5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1521	03215-1521-04
Buprenorphine	Buprenorphine 7.5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1522	03215-1522-04
Buprenorphine	Buprenorphine 10 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1523	03215-1523-04
Buprenorphine	Buprenorphine 15 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1524	03215-1524-04
Buprenorphine	Buprenorphine 20 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1525	03215-1525-04
Buprenorphine	Buprenorphine 5 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-372	50742-0372-04

All 54 Buprenorphine NDCs

Other NDCs under ANDA 207276

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

FDA NDC Directory listings under ANDA 207276
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Rhodes Pharmaceuticals LLC	42858-501
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Rhodes Pharmaceuticals LLC	42858-502
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	A-S Medication Solutions	50090-5805
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Clinical Solutions Wholesale, LLC	58118-0502
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	American Health Packaging	60687-481
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	American Health Packaging	60687-492
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Bryant Ranch Prepack	63629-9475
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-0950
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1154
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Bryant Ranch Prepack	72162-1344
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Bryant Ranch Prepack	72162-1345
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Unit Dose Solutions, Inc.	87441-011
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Unit Dose Solutions, Inc.	87441-082