Prescription drug · ANDA
Buspirone Hcl NDC 72189-235
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · Direct Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-235-30 | 72189023530 | 30 TABLET in 1 BOTTLE (72189-235-30)Marketed from Mar 16, 2022 | |
| 72189-235-60 | 72189023560 | 60 TABLET in 1 BOTTLE (72189-235-60)Marketed from Mar 16, 2022 | |
| 72189-235-90 | 72189023590 | 90 TABLET in 1 BOTTLE (72189-235-90)Marketed from Mar 16, 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 Hcl
- Generic name (nonproprietary)
- buspirone hcl
- Active ingredients
- Buspirone hydrochloride — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210907
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-235_2c2865d6-1e65-7250-e063-6394a90a6128SPL ID 2c2865d6-1e65-7250-e063-6394a90a6128SPL set ID da584ae1-4513-6474-e053-2a95a90aac9dRxCUI 866018UNII 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
N472189023530followed by a unit qualifier and the quantityPackage 72189-0235-30. 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)
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 evaluated in these studies h…
Excerpt only. Read the full label for complete information.
About NDC 72189-235
- What is NDC 72189-235?
- 72189-235 is the product NDC for Buspirone Hcl, Buspirone hydrochloride 15 mg/1 tablet, listed with the FDA by Direct Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buspirone Hcl.
- What is the active ingredient?
- Buspirone hydrochloride.
- Who is the labeler?
- Direct Rx, NDC labeler code 72189. 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 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 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9758 | 71335-9758-0171335-9758-0271335-9758-03+5 more |
| 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 210907
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 HCL | Buspirone hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-448 |
| Buspirone HCL | Buspirone hydrochloride 15 mg/1 | TabletOral | Direct_Rx | 72189-620 |
| Buspirone HCL | Buspirone hydrochloride 5 mg/1 | TabletOral | Direct_Rx | 72189-628 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-244 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-245 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-246 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-247 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-477 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-478 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5797 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-6971 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-7161 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-7652 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-0645 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2987 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2995 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3834 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7952 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7968 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8086 |
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