Vancomycin Hydrochloride NDC 69238-2261

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-2261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-2261Add 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
69238-2261-3	69238226103	80 mL in 1 BOTTLE (69238-2261-3)Marketed from Jun 26, 2023
69238-2261-5	69238226105	300 mL in 1 BOTTLE (69238-2261-5)Marketed from Jun 26, 2023
69238-2261-7	69238226107	150 mL in 1 BOTTLE (69238-2261-7)Marketed from Jun 26, 2023

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): Vancomycin Hydrochloride
Generic name (nonproprietary): vancomycin hydrochloride
Active ingredients: Vancomycin hydrochloride — 250 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215338
Marketing start: Jun 26, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Glycopeptides (Chemical structure)
Identifiers: Product ID 69238-2261_71d25621-053b-45e0-a795-60d19aa5effaSPL ID 71d25621-053b-45e0-a795-60d19aa5effaSPL set ID 3c47d5c4-8cdb-4701-8d7a-8a6e79025b53RxCUI 2000134UNII 71WO621TJDUPC 0369238226133, 0369238226157, 0369238226171
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469238226103 followed by a unit qualifier and the quantity

Package 69238-2261-03. 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 23, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile . Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)