Prescription drug · ANDA
Buspirone Hydrochloride NDC 55154-5397
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-5397-0 | 55154539700 | 10 BLISTER PACK in 1 BAG (55154-5397-0) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 31, 2010 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076008
- Marketing start
- Marketing end
- Identifiers
- Product ID 55154-5397_ebdc97e3-104e-4ad6-8854-2ef8cc896780SPL ID ebdc97e3-104e-4ad6-8854-2ef8cc896780SPL set ID 2acc7da1-d5b8-4404-a3c6-d51ed82cc4fdRxCUI 866083, 866094UNII 207LT9J9OCUPC 0055154539708, 0055154549400
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
N455154539700followed by a unit qualifier and the quantityPackage 55154-5397-00. 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 15 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1165 |
| 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 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5494 |