What is NDC 71335-2458?

71335-2458 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 30 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 7 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-2458

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2458Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2458Add 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
71335-2458-1	71335245801	60 TABLET in 1 BOTTLE, PLASTIC (71335-2458-1)Marketed from Aug 20, 2024
71335-2458-2	71335245802	30 TABLET in 1 BOTTLE, PLASTIC (71335-2458-2)Marketed from Aug 20, 2024
71335-2458-3	71335245803	56 TABLET in 1 BOTTLE, PLASTIC (71335-2458-3)Marketed from Aug 20, 2024
71335-2458-4	71335245804	90 TABLET in 1 BOTTLE, PLASTIC (71335-2458-4)Marketed from Aug 20, 2024
71335-2458-5	71335245805	180 TABLET in 1 BOTTLE, PLASTIC (71335-2458-5)Marketed from Aug 20, 2024
71335-2458-6	71335245806	15 TABLET in 1 BOTTLE, PLASTIC (71335-2458-6)Marketed from Aug 20, 2024
71335-2458-7	71335245807	120 TABLET in 1 BOTTLE, PLASTIC (71335-2458-7)Marketed from Aug 20, 2024

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 — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210907
Marketing start: Oct 17, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 71335-2458_1fb03366-6bc1-49fa-80f4-f2afeaac9d01SPL ID 1fb03366-6bc1-49fa-80f4-f2afeaac9d01SPL set ID 38faa7cb-d858-4481-8649-35d228acbd38RxCUI 866090UNII 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

N471335245801 followed by a unit qualifier and the quantity

Package 71335-2458-01. 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 Aug 20, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 evalua…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2458

What is NDC 71335-2458?: 71335-2458 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 30 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 7 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0286	55154-0286-00
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0285	55154-0285-00
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-020	87441-0020-01
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 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	72189-620
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-1749
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-6971
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3834
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-5797
Buspirone HCL	Buspirone hydrochloride 5 mg/1	TabletOral	Direct_Rx	72189-628
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7952
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Bryant Ranch Prepack	71335-2060
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 15 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7968
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2987
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8086
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2995
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	A-S Medication Solutions	50090-7652
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0505
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Asclemed USA, Inc.	76420-724
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-725
Buspirone HCL	Buspirone hydrochloride 10 mg/1	TabletOral	Direct_Rx	72189-448
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-3279

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