What is NDC 80425-0514?

80425-0514 is the product NDC for vancomycin hydrochloride, Vancomycin hydrochloride 250 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 80425-0514

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0514Add 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
80425-0514-1	8042505140180425051401	20 CAPSULE in 1 BOTTLE (80425-0514-1)Marketed from Apr 18, 2025
80425-0514-2	8042505140280425051402	30 CAPSULE in 1 BOTTLE (80425-0514-2)Marketed from Apr 18, 2025
80425-0514-3	8042505140380425051403	60 CAPSULE in 1 BOTTLE (80425-0514-3)Marketed from Apr 18, 2025
80425-0514-4	8042505140480425051404	90 CAPSULE in 1 BOTTLE (80425-0514-4)Marketed from Apr 18, 2025
80425-0514-5	8042505140580425051405	40 CAPSULE in 1 BOTTLE (80425-0514-5)Marketed from Apr 18, 2025
80425-0514-6	8042505140680425051406	50 CAPSULE in 1 BOTTLE (80425-0514-6)Marketed from Apr 18, 2025

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/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050606
Marketing start: Apr 18, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Glycopeptides (Chemical structure)
Identifiers: Product ID 80425-0514_331277b8-8300-d082-e063-6394a90a4dd3SPL ID 331277b8-8300-d082-e063-6394a90a4dd3SPL set ID 33127951-1fad-15c1-e063-6294a90a6996RxCUI 313571UNII 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

N480425051401 followed by a unit qualifier and the quantity

Package 80425-0514-01. 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 Apr 18, 2025.

Indications (excerpt from the label)

Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile -associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections. Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0514

What is NDC 80425-0514?: 80425-0514 is the product NDC for vancomycin hydrochloride, Vancomycin hydrochloride 250 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 6 package NDCs, 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?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 NDA 050606

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

FDA NDC Directory listings under NDA 050606
Product	Strength	Form · route	Labeler	Product NDC
Vancocinvancomycin hydrochloride	Vancomycin hydrochloride 125 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	62559-310
Vancocinvancomycin hydrochloride	Vancomycin hydrochloride 250 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	62559-311
vancomycin hydrochloride	Vancomycin hydrochloride 125 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	62559-390
vancomycin hydrochloride	Vancomycin hydrochloride 250 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	62559-391
vancomycin hydrochloride	Vancomycin hydrochloride 125 mg/1	CapsuleOral	Redpharm Drug	67296-2143