What is NDC 71335-0253?

71335-0253 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 6 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 71335-0253

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0253Add 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
71335-0253-1	71335025301	90 TABLET in 1 BOTTLE (71335-0253-1)Marketed from Jul 9, 2024
71335-0253-2	71335025302	45 TABLET in 1 BOTTLE (71335-0253-2)Marketed from Jul 9, 2024
71335-0253-3	71335025303	30 TABLET in 1 BOTTLE (71335-0253-3)Marketed from Jul 9, 2024
71335-0253-4	71335025304	60 TABLET in 1 BOTTLE (71335-0253-4)Marketed from Mar 5, 2018
71335-0253-5	71335025305	180 TABLET in 1 BOTTLE (71335-0253-5)Marketed from Jul 9, 2024
71335-0253-6	71335025306	120 TABLET in 1 BOTTLE (71335-0253-6)Marketed from Jul 9, 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 — 5 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 075022
Marketing start: Feb 28, 2002
Listing expires: Dec 31, 2026
Identifiers: Product ID 71335-0253_fa7aedac-e465-4ae7-b725-0d037f3d3668SPL ID fa7aedac-e465-4ae7-b725-0d037f3d3668SPL set ID db32a7ec-5b50-4305-8952-df22e7e871e2RxCUI 866083, 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

N471335025301 followed by a unit qualifier and the quantity

Package 71335-0253-01. 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 Jul 9, 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 71335-0253

What is NDC 71335-0253?: 71335-0253 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 6 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 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 075022

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

FDA NDC Directory listings under ANDA 075022
Product	Strength	Form · route	Labeler	Product NDC
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-974
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	83209-303
Buspirone Hydrochloridebuspirone	Buspirone hydrochloride 10 mg/1	TabletOral	Boswell Pharmacy Services d/b/a BPS Wholesale	83209-554
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Proficient Rx LP	63187-904
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Proficient Rx LP	71205-799
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-0053
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-5200
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-0054
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-5886
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7689
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	A-S Medication Solutions	50090-6719
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-1003
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Northwind Health Company, LLC	51655-015
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3881
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7714
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8527
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7718
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Proficient Rx LP	63187-402
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-1105
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-183

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