What is NDC 80425-0334?

80425-0334 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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 Buspirone Hydrochloride?

260 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buspirone Hydrochloride NDC 80425-0334

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0334Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0334Add 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
80425-0334-1	8042503340180425033401	30 TABLET in 1 BOTTLE (80425-0334-1)Marketed from May 19, 2023
80425-0334-2	8042503340280425033402	60 TABLET in 1 BOTTLE (80425-0334-2)Marketed from May 19, 2023
80425-0334-3	8042503340380425033403	90 TABLET in 1 BOTTLE (80425-0334-3)Marketed from May 19, 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): Buspirone Hydrochloride
Generic name (nonproprietary): buspirone hydrochloride
Active ingredients: Buspirone hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078246
Marketing start: May 19, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 80425-0334_2a9bad62-b308-697c-e063-6294a90aa395SPL ID 2a9bad62-b308-697c-e063-6294a90aa395SPL set ID fc0f93c8-2078-b2ff-e053-6294a90aacdfRxCUI 866094UNII 207LT9J9OC

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

N480425033401 followed by a unit qualifier and the quantity

Package 80425-0334-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these st…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0334

What is NDC 80425-0334?: 80425-0334 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Buspirone Hydrochloride.
What is the active ingredient?: Buspirone hydrochloride.
Who is the labeler?: Advanced Rx Pharmacy 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 Buspirone Hydrochloride?: 260 other product NDCs are listed under this name. See all Buspirone 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 Buspirone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buspirone hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	American Health Packaging	60687-988	60687-0988-01
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0285	55154-0285-00
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0286	55154-0286-00
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-018	87441-0018-01
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-019	87441-0019-01
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-020	87441-0020-01
Buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Coupler LLC	67046-1352	67046-1352-03
Buspirone Hydrochloride	Buspirone hydrochloride 12.5 mg/1	TabletOral	IPG Pharmaceuticals, Inc	71085-094	71085-0094-30
Buspirone Hydrochloride	Buspirone hydrochloride 2.5 mg/1	TabletOral	IPG Pharmaceuticals, Inc	71085-093	71085-0093-60
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Coupler LLC	67046-0645	67046-0645-03

All 261 Buspirone Hydrochloride NDCs

Other NDCs under ANDA 078246

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

FDA NDC Directory listings under ANDA 078246
Product	Strength	Form · route	Labeler	Product NDC
Buspirone Hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-2193
Buspirone Hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Proficient Rx LP	82804-039
Buspirone Hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	A-S Medication Solutions	50090-7075
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-389
Buspirone Hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-390
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Aurobindo Pharma Limited	59651-391
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Aurobindo Pharma Limited	59651-392
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Aurobindo Pharma Limited	59651-393
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Bryant Ranch Prepack	71335-2073
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2081
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-6188
Buspirone Hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4317