Prescription drug · ANDA
Buspirone Hydrochloride NDC 71610-208
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-208-53 | 71610020853 | 60 TABLET in 1 BOTTLE (71610-208-53)Marketed from Dec 13, 2018 | |
| 71610-208-60 | 71610020860 | 90 TABLET in 1 BOTTLE (71610-208-60)Marketed from Dec 13, 2018 | |
| 71610-208-80 | 71610020880 | 180 TABLET in 1 BOTTLE (71610-208-80)Marketed from Dec 13, 2018 |
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 202557
- Marketing start
- Listing expires
- Identifiers
- Product ID 71610-208_9f977fa3-9302-4338-a22b-a3ac042e82daSPL ID 9f977fa3-9302-4338-a22b-a3ac042e82daSPL set ID fac49d42-7bc0-435f-bce2-2548dcdd6de6RxCUI 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
N471610020853followed by a unit qualifier and the quantityPackage 71610-0208-53. 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 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.
Other NDCs under ANDA 202557
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 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-785 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-201 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-200 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-202 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-203 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-289 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-511 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Direct_Rx | 61919-166 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3336 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | DIRECT RX | 72189-175 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-165 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5614 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0007 |