Prescription drug · ANDA
Buspirone Hydrochloride NDC 71335-2768
Buspirone hydrochloride 30 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2768-1 | 71335276801 | 60 TABLET in 1 BOTTLE (71335-2768-1)Marketed from Oct 3, 2025 | |
| 71335-2768-2 | 71335276802 | 30 TABLET in 1 BOTTLE (71335-2768-2)Marketed from Oct 3, 2025 | |
| 71335-2768-3 | 71335276803 | 56 TABLET in 1 BOTTLE (71335-2768-3)Marketed from Oct 3, 2025 | |
| 71335-2768-4 | 71335276804 | 90 TABLET in 1 BOTTLE (71335-2768-4)Marketed from Oct 3, 2025 | |
| 71335-2768-5 | 71335276805 | 180 TABLET in 1 BOTTLE (71335-2768-5)Marketed from Oct 3, 2025 | |
| 71335-2768-6 | 71335276806 | 15 TABLET in 1 BOTTLE (71335-2768-6)Marketed from Oct 3, 2025 | |
| 71335-2768-7 | 71335276807 | 120 TABLET in 1 BOTTLE (71335-2768-7)Marketed from Oct 3, 2025 |
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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078302
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2768_98aa0336-0e99-4d64-a08e-0c96e49edf85SPL ID 98aa0336-0e99-4d64-a08e-0c96e49edf85SPL set ID 790b6159-c03b-4a3a-be6b-add35a3114a4RxCUI 866090UNII 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
N471335276801followed by a unit qualifier and the quantityPackage 71335-2768-01. 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 .
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.
Other NDCs under ANDA 078302
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 30 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-094 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1927 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-7742 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-142 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2414 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2415 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Proficient Rx LP | 82804-964 |