Vancomycin Hydrochloride NDC 63629-1970

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-1970Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-1970Add 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
63629-1970-1	63629197001	80 mL in 1 BOTTLE (63629-1970-1)Marketed from Sep 9, 2019

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: Powder, For solution
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 061667
Marketing start: Sep 9, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Glycopeptides (Chemical structure)
Identifiers: Product ID 63629-1970_1802535f-1eaa-48d2-8cfc-b0e6c0c07297SPL ID 1802535f-1eaa-48d2-8cfc-b0e6c0c07297SPL set ID 786bde33-9aec-4b4d-ba46-90bfd61956d0RxCUI 2000134UNII 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 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

N463629197001 followed by a unit qualifier and the quantity

Package 63629-1970-01. 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 May 26, 2026.

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)

Other NDCs under ANDA 061667

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

FDA NDC Directory listings under ANDA 061667
Product	Strength	Form · route	Labeler	Product NDC
Vancomycin Hydrochloride	Vancomycin hydrochloride 250 mg/5mL	Powder, For solutionOral	Bryant Ranch Prepack	72162-1775
Vancomycin Hydrochloride	Vancomycin hydrochloride 250 mg/5mL	Powder, For solutionOral	Bryant Ranch Prepack	71335-2950
Vancomycin Hydrochloride	Vancomycin hydrochloride 250 mg/5mL	Powder, For solutionOral	Bryant Ranch Prepack	71335-2948
Vancomycin Hydrochloride	Vancomycin hydrochloride 250 mg/5mL	Powder, For solutionOral	ANI Pharmaceuticals, Inc.	62559-830
Vancomycin Hydrochloride	Vancomycin hydrochloride 250 mg/5mL	Powder, For solutionOral	Bryant Ranch Prepack	63629-1971
Vancomycin Hydrochloride	Vancomycin hydrochloride 250 mg/5mL	Powder, For solutionOral	Bryant Ranch Prepack	63629-1972