Prescription drug · ANDA
Buspirone Hydrochloride NDC 0378-1165
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-1165-05 | 00378116505 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-1165-05)Marketed from Mar 29, 2001 | |
| 0378-1165-80 | 00378116580 | 180 TABLET in 1 BOTTLE, PLASTIC (0378-1165-80)Marketed from Mar 29, 2001 | |
| 0378-1165-91 | 00378116591 | 60 TABLET in 1 BOTTLE, PLASTIC (0378-1165-91)Marketed from Mar 28, 2001 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076008
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-1165_590dcfd9-dcb7-4aa9-8a75-c7f1acbd148fSPL ID 590dcfd9-dcb7-4aa9-8a75-c7f1acbd148fSPL set ID 7c9eafb9-9ce1-4b28-900c-8fcb4b23424eRxCUI 866018, 866083, 866090, 866094UNII 207LT9J9OCUPC 0303781165051, 0303781175913, 0303781150057, 0303781140058
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
N400378116505followed by a unit qualifier and the quantityPackage 00378-1165-05. 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 076008
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 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1140 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-960 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-985 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-986 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-994 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1175 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1150 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0285 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0286 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Safecor Health, LLC | 48433-013 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Safecor Health, LLC | 48433-011 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-012 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Safecor Health, LLC | 48433-014 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5397 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5494 |