Prescription drug · ANDA
Buspirone hydrochloride NDC 50268-135
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-135-15 | 50268013515 | 50 BLISTER PACK in 1 BOX (50268-135-15) / 1 TABLET in 1 BLISTER PACK (50268-135-11)Marketed from Oct 21, 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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078888
- Marketing start
- Listing expires
- Identifiers
- Product ID 50268-135_4c3657a8-f6bd-b2a4-e063-6394a90a741dSPL ID 4c3657a8-f6bd-b2a4-e063-6394a90a741dSPL set ID b230197c-3d50-7874-e053-2a95a90af50fRxCUI 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
N450268013515followed by a unit qualifier and the quantityPackage 50268-0135-15. 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 have 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 s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078888
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 | Cardinal Health 107, LLC | 55154-3364 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2199 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-019 |
| buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-783 |
| buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-781 |
| buspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-782 |
| buspirone hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-784 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-623 |
| buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-842 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3906 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-206 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2237 |
| Buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-266 |
| Buspirone hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-183 |
| Buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-180 |
| Buspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-181 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-182 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6899 |
| Buspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0222 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2820 |
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