What is NDC 67457-339?

67457-339 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Vancomycin Hydrochloride?

128 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vancomycin Hydrochloride NDC 67457-339

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-339Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0339Add 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
67457-339-50	6745703395067457033950	10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00)Marketed from Dec 5, 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): Vancomycin Hydrochloride
Generic name (nonproprietary): vancomycin hydrochloride
Active ingredients: Vancomycin hydrochloride — 500 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065397
Marketing start: Dec 5, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Glycopeptides (Chemical structure)
Identifiers: Product ID 67457-339_1569b5e0-e953-43ea-a5d1-822c921ae5feSPL ID 1569b5e0-e953-43ea-a5d1-822c921ae5feSPL set ID 2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdfRxCUI 1807513, 1807516UNII 71WO621TJD
Pharmacologic class: Glycopeptide Antibacterial

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N467457033950 followed by a unit qualifier and the quantity

Package 67457-0339-50. 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 Jun 1, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-339

What is NDC 67457-339?: 67457-339 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vancomycin Hydrochloride.
What is the active ingredient?: Vancomycin hydrochloride.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vancomycin Hydrochloride?: 128 other product NDCs are listed under this name. See all Vancomycin Hydrochloride 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 Vancomycin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Vancomycin Hydrochloride	Vancomycin hydrochloride 5 g/100mL	Injection, Powder, Lyophilized, For solutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-957	68462-0957-05
Vancomycin Hydrochloride	Vancomycin hydrochloride 10 g/100mL	Injection, Powder, Lyophilized, For solutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-958	68462-0958-10
Vancomycin Hydrochloride	Vancomycin hydrochloride 750 mg/1	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-114	83634-0114-20
Vancomycin Hydrochloride	Vancomycin hydrochloride 1.25 g/1	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-115	83634-0115-30
Vancomycin Hydrochloride	Vancomycin hydrochloride 1.5 g/1	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-116	83634-0116-30
vancomycin hydrochloride	Vancomycin hydrochloride 125 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-967	23155-0967-2523155-0967-78
vancomycin hydrochloride	Vancomycin hydrochloride 250 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-968	23155-0968-2523155-0968-78
vancomycin hydrochloride	—	Kit	Aurobindo Pharma Limited	59651-669	59651-0669-0359651-0669-55
vancomycin hydrochloride	—	Kit	Aurobindo Pharma Limited	59651-670	59651-0670-0359651-0670-55
Vancomycin Hydrochloride	Vancomycin hydrochloride 125 mg/1	CapsuleOral	PAI Holdings, LLC dba PAI Pharma	0121-1032	00121-1032-2000121-1032-50

All 129 Vancomycin Hydrochloride NDCs

Other NDCs under ANDA 065397

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

FDA NDC Directory listings under ANDA 065397
Product	Strength	Form · route	Labeler	Product NDC
Vancomycin Hydrochloride	Vancomycin hydrochloride 1 g/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Mylan Institutional LLC	67457-340