What is NDC 71610-266?

71610-266 is the product NDC for Buspirone hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-266 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-266Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0266Add 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
71610-266-53	71610026653	60 TABLET in 1 BOTTLE (71610-266-53)Marketed from Apr 25, 2019
71610-266-60	71610026660	90 TABLET in 1 BOTTLE (71610-266-60)Marketed from Apr 25, 2019
71610-266-80	71610026680	180 TABLET in 1 BOTTLE (71610-266-80)Marketed from Apr 25, 2019

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 hydrochloride
Generic name (nonproprietary): buspirone hydrochloride
Active ingredients: Buspirone hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078888
Marketing start: May 3, 2014
Listing expires: Dec 31, 2026
Identifiers: Product ID 71610-266_bbf54820-016c-4a8b-b50c-1ce5e26f4c3eSPL ID bbf54820-016c-4a8b-b50c-1ce5e26f4c3eSPL set ID 7f6986a8-59dc-4dc3-bac0-b38cfc689f8fRxCUI 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

N471610026653 followed by a unit qualifier and the quantity

Package 71610-0266-53. 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 Apr 29, 2019.

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 have 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-266

What is NDC 71610-266?: 71610-266 is the product NDC for Buspirone hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 078888

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

FDA NDC Directory listings under ANDA 078888
Product	Strength	Form · route	Labeler	Product NDC
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Major Pharmaceuticals	0904-6899
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	AvPAK	50268-135
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3364
Buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	American Health Packaging	60687-801
Buspirone hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	American Health Packaging	60687-812
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	American Health Packaging	60687-823
buspirone hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-781
buspirone hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Zydus Lifesciences Limited	65841-782
buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Zydus Lifesciences Limited	65841-783
buspirone hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Zydus Lifesciences Limited	65841-784
buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-842
Buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Coupler LLC	67046-1352
Buspirone hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-180
Buspirone hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-181
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-182
Buspirone hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-183
Buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-623
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	REMEDYREPACK INC.	70518-0380
Buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-3906
Buspirone hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-0222

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