Prescription drug · ANDA
Buspirone Hydrochloride NDC 72189-200
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-200-82 | 72189020082 | 180 TABLET in 1 BOTTLE (72189-200-82)Marketed from Apr 12, 2021 |
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
- Labeler
- DIRECT RX
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202330
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-200_4c498a8f-f65a-5df5-e063-6394a90ae0fdSPL ID 4c498a8f-f65a-5df5-e063-6394a90ae0fdSPL set ID bae98d45-e192-56e3-e053-2a95a90aadc3RxCUI 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
N472189020082followed by a unit qualifier and the quantityPackage 72189-0200-82. 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 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 studies had experienced …
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 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 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Strides Pharma Inc. | 42543-787 |
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