What is NDC 72189-448?

72189-448 is the product NDC for Buspirone HCL, Buspirone hydrochloride 10 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 HCL?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buspirone HCL NDC 72189-448 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0448Add 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
72189-448-30	72189044830	30 TABLET in 1 BOTTLE (72189-448-30)Marketed from Mar 17, 2023
72189-448-60	72189044860	60 TABLET in 1 BOTTLE (72189-448-60)Marketed from Mar 17, 2023
72189-448-82	72189044882	180 TABLET in 1 BOTTLE (72189-448-82)Marketed from Mar 17, 2023
72189-448-90	72189044890	90 TABLET in 1 BOTTLE (72189-448-90)Marketed from Mar 17, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 HCL
Generic name (nonproprietary): buspirone hcl
Active ingredients: Buspirone hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210907
Marketing start: Mar 17, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-448_2f365a80-62cf-95d6-e063-6394a90af5c5SPL ID 2f365a80-62cf-95d6-e063-6394a90af5c5SPL set ID f71e019b-3928-f8eb-e053-6394a90a871eRxCUI 866083UNII 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

N472189044830 followed by a unit qualifier and the quantity

Package 72189-0448-30. 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 Feb 28, 2025.

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 72189-448

What is NDC 72189-448?: 72189-448 is the product NDC for Buspirone HCL, Buspirone hydrochloride 10 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Buspirone HCL.
What is the active ingredient?: Buspirone hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 HCL?: 11 other product NDCs are listed under this name. See all Buspirone HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
busPIRone HClbuspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Northwind Health Company, LLC	82868-082	82868-0082-30
Buspirone HCL	Buspirone hydrochloride 5 mg/1	TabletOral	Direct_Rx	72189-628	72189-0628-90
Buspirone HCL	Buspirone hydrochloride 15 mg/1	TabletOral	Direct_Rx	72189-620	72189-0620-3072189-0620-6072189-0620-90
Buspirone HCL	Buspirone hydrochloride 7.5 mg/1	TabletOral	Direct_Rx	72189-458	72189-0458-30
Buspirone Hcl	Buspirone hydrochloride 15 mg/1	TabletOral	Direct Rx	72189-235	72189-0235-3072189-0235-6072189-0235-90
busPIRone HClbuspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Advagen Pharma Ltd	72888-063	72888-0063-0172888-0063-05
busPIRone HClbuspirone hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Advagen Pharma Ltd	72888-066	72888-0066-0572888-0066-60
busPIRone HClbuspirone hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-9758	71335-9758-0171335-9758-0271335-9758-03+5 more
busPIRone HClbuspirone hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Advagen Pharma Ltd	72888-062	72888-0062-0172888-0062-05
busPIRone HClbuspirone hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Advagen Pharma Ltd	72888-064	72888-0064-0172888-0064-05

All 12 Buspirone HCL 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 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
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8086

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