Prescription drug · ANDA

Buspirone Hydrochloride NDC 71610-943

Buspirone hydrochloride 5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-943Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0943Add 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 NDC11-digit (billing)PackageCopy
71610-943-537161009435360 TABLET in 1 BOTTLE (71610-943-53)Marketed from Sep 2, 2025
71610-943-607161009436090 TABLET in 1 BOTTLE (71610-943-60)Marketed from Sep 2, 2025
71610-943-8071610094380180 TABLET in 1 BOTTLE (71610-943-80)Marketed from Sep 2, 2025
71610-943-9271610094392270 TABLET in 1 BOTTLE (71610-943-92)Marketed from Sep 3, 2025

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 075388
Marketing start
Listing expires
Identifiers
Product ID 71610-943_3e4b22e7-e800-e5b1-e063-6294a90a6d49SPL ID 3e4b22e7-e800-e5b1-e063-6294a90a6d49SPL set ID 3dd7f213-afd8-67d6-e063-6294a90ac108RxCUI 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

N471610094353 followed by a unit qualifier and the quantity

Package 71610-0943-53. 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 .

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 71610-943

What is NDC 71610-943?
71610-943 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 4 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCardinal Health 107, LLC55154-028555154-0285-00
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralCardinal Health 107, LLC55154-028655154-0286-00
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-01887441-0018-01
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralUnit Dose Solutions, Inc.87441-01987441-0019-01
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-02087441-0020-01
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralCoupler LLC67046-135267046-1352-03
Buspirone HydrochlorideBuspirone hydrochloride 2.5 mg/1TabletOralIPG Pharmaceuticals, Inc71085-09371085-0093-60
Buspirone HydrochlorideBuspirone hydrochloride 12.5 mg/1TabletOralIPG Pharmaceuticals, Inc71085-09471085-0094-30
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCoupler LLC67046-064567046-0645-03
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralREMEDYREPACK INC.70518-458670518-4586-00

All 260 Buspirone Hydrochloride NDCs

Other NDCs under ANDA 075388

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

FDA NDC Directory listings under ANDA 075388
ProductStrengthForm · routeLabelerProduct NDC
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralA-S Medication Solutions50090-6649
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralA-S Medication Solutions50090-7293
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralA-S Medication Solutions50090-7682
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralA-S Medication Solutions50090-7785
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack63629-2408
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack63629-2409
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralBryant Ranch Prepack63629-2410
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralBryant Ranch Prepack63629-2411
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralBryant Ranch Prepack63629-2412
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralBryant Ranch Prepack63629-2413
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralOxford Pharmaceuticals, LLC69584-091
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralOxford Pharmaceuticals, LLC69584-092
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralOxford Pharmaceuticals, LLC69584-093
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralREMEDYREPACK INC.70518-2987
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-4443
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralREMEDYREPACK INC.70518-4586
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralBryant Ranch Prepack71335-1752
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack71335-1938
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-9673
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-953

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