Prescription drug · ANDA
Buspirone Hydrochloride NDC 51655-796
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-796-26 | 51655079626 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-796-26)Marketed from Feb 18, 2022 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202330
- Marketing start
- Listing expires
- Identifiers
- Product ID 51655-796_4ba8aa52-6d36-c075-e063-6294a90a25a0SPL ID 4ba8aa52-6d36-c075-e063-6294a90a25a0SPL set ID d9de7cf1-c38d-8b3c-e053-2995a90aa26bRxCUI 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
N451655079626followed by a unit qualifier and the quantityPackage 51655-0796-26. 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 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 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202330
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8434 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5347 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0682 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-826 |
| Buspirone HCL | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Direct_Rx | 72189-458 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-743 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-741 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-742 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-744 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-596 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-604 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-608 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | DIRECT RX | 72189-200 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-787 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-640 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Strides Pharma Inc. | 42543-744 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Strides Pharma Inc. | 42543-741 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Strides Pharma Inc. | 42543-742 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Strides Pharma Inc. | 42543-743 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1930 |
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