Prescription drug · ANDA
busPIRone HCl (Buspirone hydrochloride) NDC 71335-9758
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9758-1 | 7133597580171335975801 | 30 TABLET in 1 BOTTLE (71335-9758-1)Marketed from Oct 4, 2023 | |
| 71335-9758-2 | 7133597580271335975802 | 60 TABLET in 1 BOTTLE (71335-9758-2)Marketed from Nov 30, 2023 | |
| 71335-9758-3 | 7133597580371335975803 | 90 TABLET in 1 BOTTLE (71335-9758-3)Marketed from Nov 20, 2023 | |
| 71335-9758-4 | 7133597580471335975804 | 45 TABLET in 1 BOTTLE (71335-9758-4)Marketed from Apr 8, 2026 | |
| 71335-9758-5 | 7133597580571335975805 | 180 TABLET in 1 BOTTLE (71335-9758-5)Marketed from Jul 20, 2023 | |
| 71335-9758-6 | 7133597580671335975806 | 120 TABLET in 1 BOTTLE (71335-9758-6)Marketed from Apr 8, 2026 | |
| 71335-9758-7 | 7133597580771335975807 | 10 TABLET in 1 BOTTLE (71335-9758-7)Marketed from Apr 8, 2026 | |
| 71335-9758-8 | 7133597580871335975808 | 100 TABLET in 1 BOTTLE (71335-9758-8)Marketed from Apr 8, 2026 |
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 HCl
- Generic name (nonproprietary)
- buspirone hydrochloride
- Active ingredients
- Buspirone hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075521
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-9758_58de542f-8f84-4d8d-b922-0ca2293f1e66SPL ID 58de542f-8f84-4d8d-b922-0ca2293f1e66SPL set ID 138b84a5-966b-47d7-a3d6-395df83f8aa5RxCUI 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
N471335975801followed by a unit qualifier and the quantityPackage 71335-9758-01. 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 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.
About NDC 71335-9758
- What is NDC 71335-9758?
- 71335-9758 is the product NDC for busPIRone HCl (buspirone hydrochloride), Buspirone hydrochloride 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- busPIRone HCl (Buspirone hydrochloride).
- What is the active ingredient?
- Buspirone hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 HCl?
- 11 other product NDCs are listed under this name. See all busPIRone HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other busPIRone HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-082 | 82868-0082-30 |
| Buspirone HCL | Buspirone hydrochloride 5 mg/1 | TabletOral | Direct_Rx | 72189-628 | 72189-0628-90 |
| Buspirone HCL | Buspirone hydrochloride 15 mg/1 | TabletOral | Direct_Rx | 72189-620 | 72189-0620-3072189-0620-6072189-0620-90 |
| Buspirone HCL | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Direct_Rx | 72189-458 | 72189-0458-30 |
| Buspirone HCL | Buspirone hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-448 | 72189-0448-3072189-0448-6072189-0448-82+1 more |
| Buspirone Hcl | Buspirone hydrochloride 15 mg/1 | TabletOral | Direct Rx | 72189-235 | 72189-0235-3072189-0235-6072189-0235-90 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-063 | 72888-0063-0172888-0063-05 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-066 | 72888-0066-0572888-0066-60 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-062 | 72888-0062-0172888-0062-05 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-064 | 72888-0064-0172888-0064-05 |
Other NDCs under ANDA 075521
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 HClbuspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-062 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-063 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-064 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-065 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-066 |
| busPIRone HClbuspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-082 |