Prescription drug · ANDA
Buspirone Hydrochloride NDC 71335-1605
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1605-1 | 71335160501 | 30 TABLET in 1 BOTTLE (71335-1605-1)Marketed from May 20, 2024 | |
| 71335-1605-2 | 71335160502 | 100 TABLET in 1 BOTTLE (71335-1605-2)Marketed from May 20, 2024 | |
| 71335-1605-3 | 71335160503 | 60 TABLET in 1 BOTTLE (71335-1605-3)Marketed from May 29, 2020 | |
| 71335-1605-4 | 71335160504 | 90 TABLET in 1 BOTTLE (71335-1605-4)Marketed from May 27, 2020 | |
| 71335-1605-5 | 71335160505 | 120 TABLET in 1 BOTTLE (71335-1605-5)Marketed from May 20, 2024 | |
| 71335-1605-6 | 71335160506 | 28 TABLET in 1 BOTTLE (71335-1605-6)Marketed from May 20, 2024 | |
| 71335-1605-7 | 71335160507 | 180 TABLET in 1 BOTTLE (71335-1605-7)Marketed from May 20, 2024 |
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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204582
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1605_c45202e2-c467-43ea-b93b-e54672271cc2SPL ID c45202e2-c467-43ea-b93b-e54672271cc2SPL set ID 225575f1-9635-4922-8286-d479d6480bf0RxCUI 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
N471335160501followed by a unit qualifier and the quantityPackage 71335-1605-01. 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 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1608 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-023 |
| 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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-025 |
| 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 |