Prescription drug · ANDA
Buspirone Hydrochloride NDC 24689-785
Buspirone hydrochloride 7.5 mg/1 · Tablet · Oral · APNAR PHARMA LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24689-785-01 | 24689078501 | 100 TABLET in 1 BOTTLE (24689-785-01)Marketed from Jun 17, 2024 |
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 — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- APNAR PHARMA LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209696
- Marketing start
- Listing expires
- Identifiers
- Product ID 24689-785_19f3df29-51b2-7f8b-e063-6294a90a542fSPL ID 19f3df29-51b2-7f8b-e063-6294a90a542fSPL set ID 3c115eea-9dbc-4e2c-9d79-42e3388fde5aRxCUI 866018, 866083, 866090, 866094, 866111UNII 207LT9J9OCUPC 0324689921068, 0324689921051, 0324689781013, 0324689785011, 0324689921013, 0324689907017, 0324689933061, 0324689907055, 0324689781051
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
N424689078501followed by a unit qualifier and the quantityPackage 24689-0785-01. 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 disorder 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 stu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209696
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 | Proficient Rx LP | 71205-280 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1144 |
| BusPIRone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-291 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | APNAR PHARMA LP | 24689-781 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | APNAR PHARMA LP | 24689-921 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | APNAR PHARMA LP | 24689-907 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | APNAR PHARMA LP | 24689-933 |