Vancomycin Hydrochloride NDC 63323-295

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-295Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0295Add 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
63323-295-61	63323029561	1 BOTTLE in 1 CARTON (63323-295-61) / 100 mL in 1 BOTTLEMarketed from Jul 17, 2001

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 — 5 g/100mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062663
Marketing start: Jul 17, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Glycopeptides (Chemical structure)
Identifiers: Product ID 63323-295_61ca1076-563b-48b2-9632-4f9a88f7639aSPL ID 61ca1076-563b-48b2-9632-4f9a88f7639aSPL set ID d3147f2d-1a72-4923-874b-8fdee2be625eRxCUI 239209, 313572UNII 71WO621TJDUPC 0363323295615, 0363323314613
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

N463323029561 followed by a unit qualifier and the quantity

Package 63323-0295-61. 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 Sep 30, 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)

Other NDCs under ANDA 062663

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

FDA NDC Directory listings under ANDA 062663
Product	Strength	Form · route	Labeler	Product NDC
Vancomycin Hydrochloride	Vancomycin hydrochloride 1 g/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-284
Vancomycin Hydrochloride	Vancomycin hydrochloride 1 g/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-284
Vancomycin Hydrochloride	Vancomycin hydrochloride 1 g/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-284
Vancomycin Hydrochloride	Vancomycin hydrochloride 10 g/100mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-314
Vancomycin Hydrochloride	Vancomycin hydrochloride 10 g/100mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-314
Vancomycin Hydrochloride	Vancomycin hydrochloride 750 mg/15mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-203
Vancomycin Hydrochloride	Vancomycin hydrochloride 750 mg/15mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-203
Vancomycin Hydrochloride	Vancomycin hydrochloride 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-221
Vancomycin Hydrochloride	Vancomycin hydrochloride 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-221