Prescription drug · ANDA
Buspirone Hydrochloride NDC 69584-091
Buspirone hydrochloride 5 mg/1 · Tablet · Oral · Oxford Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69584-091-10 | 69584009110 | 100 TABLET in 1 BOTTLE (69584-091-10)Marketed from Jul 27, 2020 | |
| 69584-091-50 | 69584009150 | 500 TABLET in 1 BOTTLE (69584-091-50)Marketed from Jul 27, 2020 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Oxford Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075388
- Marketing start
- Listing expires
- Identifiers
- Product ID 69584-091_8c9f66ca-78a9-418c-b11e-ba4391843257SPL ID 8c9f66ca-78a9-418c-b11e-ba4391843257SPL set ID 97fcebc1-6615-4b9d-b0f3-6434850f407cRxCUI 866018, 866083, 866090, 866094UNII 207LT9J9OCUPC 0369584093502
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
N469584009110followed by a unit qualifier and the quantityPackage 69584-0091-10. 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 075388
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 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2987 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-332 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-092 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-093 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7682 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1926 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1924 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1925 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-140 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-139 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-141 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1938 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4586 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9673 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2409 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2408 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2413 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2410 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2411 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2412 |
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