Prescription drug · ANDA
Buspirone Hydrochloride NDC 23155-023
Buspirone hydrochloride 5 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-023-01 | 23155002301 | 100 TABLET in 1 BOTTLE (23155-023-01)Marketed from Sep 18, 2015 | |
| 23155-023-05 | 23155002305 | 500 TABLET in 1 BOTTLE (23155-023-05)Marketed from Sep 20, 2018 | |
| 23155-023-10 | 23155002310 | 1000 TABLET in 1 BOTTLE (23155-023-10)Marketed from Sep 20, 2018 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204582
- Marketing start
- Listing expires
- Identifiers
- Product ID 23155-023_5cb34079-0b3b-4c4e-b5a8-bfcdb21d7c3bSPL ID 5cb34079-0b3b-4c4e-b5a8-bfcdb21d7c3bSPL set ID 4ff72575-bd60-40ce-b3a8-fd92b79af674RxCUI 866018, 866083, 866090, 866094UNII 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
N423155002301followed by a unit qualifier and the quantityPackage 23155-0023-01. 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 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 st…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204582
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 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2031 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-097 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4305 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7121 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4312 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7122 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1605 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1608 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-025 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-024 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2660 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-097 |