What is NDC 80425-0303?

80425-0303 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 15 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?

259 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 80425-0303

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0303Add 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
80425-0303-1	80425030301	30 TABLET in 1 BOTTLE (80425-0303-1)Marketed from Apr 6, 2023
80425-0303-2	80425030302	60 TABLET in 1 BOTTLE (80425-0303-2)Marketed from Apr 6, 2023
80425-0303-3	80425030303	90 TABLET in 1 BOTTLE (80425-0303-3)Marketed from Apr 6, 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 — 15 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 210907
Marketing start: Apr 6, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 80425-0303_2a9c0c91-2b32-4def-e063-6294a90a58efSPL ID 2a9c0c91-2b32-4def-e063-6294a90a58efSPL set ID f8afd9b8-0885-2f0c-e053-6294a90a9c57RxCUI 866018UNII 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

N480425030301 followed by a unit qualifier and the quantity

Package 80425-0303-01. 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)

Buspirone hydrochloride tablets, USP 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, USP 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, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies h…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0303

What is NDC 80425-0303?: 80425-0303 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 15 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?: 259 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	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 2.5 mg/1	TabletOral	IPG Pharmaceuticals, Inc	71085-093	71085-0093-60
Buspirone Hydrochloride	Buspirone hydrochloride 12.5 mg/1	TabletOral	IPG Pharmaceuticals, Inc	71085-094	71085-0094-30
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Coupler LLC	67046-0645	67046-0645-03
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4586	70518-4586-00

All 260 Buspirone Hydrochloride NDCs

Other NDCs under ANDA 210907

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

FDA NDC Directory listings under ANDA 210907
Product	Strength	Form · route	Labeler	Product NDC
Buspirone Hcl	Buspirone hydrochloride 15 mg/1	TabletOral	Direct Rx	72189-235
Buspirone HCL	Buspirone hydrochloride 10 mg/1	TabletOral	Direct_Rx	72189-448
Buspirone HCL	Buspirone hydrochloride 15 mg/1	TabletOral	Direct_Rx	72189-620
Buspirone HCL	Buspirone hydrochloride 5 mg/1	TabletOral	Direct_Rx	72189-628
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-244
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-245
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-246
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-247
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-477
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-478
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-5797
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-6971
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-7161
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	A-S Medication Solutions	50090-7652
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Coupler LLC	67046-0645
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2987
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2995
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3834
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7952
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7968

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