Prescription drug · ANDA
BusPIRone Hydrochloride NDC 71610-291
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-291-60 | 7161002916071610029160 | 90 TABLET in 1 BOTTLE (71610-291-60)Marketed from Jun 5, 2019 |
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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209696
- Marketing start
- Listing expires
- Identifiers
- Product ID 71610-291_ab84266e-acad-41f9-ada7-9a54817dd289SPL ID ab84266e-acad-41f9-ada7-9a54817dd289SPL set ID e2c672b3-6130-4dd1-8066-0ce9451cb8c7RxCUI 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
N471610029160followed by a unit qualifier and the quantityPackage 71610-0291-60. 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.
About NDC 71610-291
- What is NDC 71610-291?
- 71610-291 is the product NDC for BusPIRone Hydrochloride, Buspirone hydrochloride 15 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BusPIRone Hydrochloride.
- What is the active ingredient?
- Buspirone hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BusPIRone Hydrochloride?
- 260 other product NDCs are listed under this name. See all BusPIRone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other BusPIRone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-988 | 60687-0988-01 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0285 | 55154-0285-00 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0286 | 55154-0286-00 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-018 | 87441-0018-01 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-019 | 87441-0019-01 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-020 | 87441-0020-01 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Coupler LLC | 67046-1352 | 67046-1352-03 |
| Buspirone Hydrochloride | Buspirone hydrochloride 12.5 mg/1 | TabletOral | IPG Pharmaceuticals, Inc | 71085-094 | 71085-0094-30 |
| Buspirone Hydrochloride | Buspirone hydrochloride 2.5 mg/1 | TabletOral | IPG Pharmaceuticals, Inc | 71085-093 | 71085-0093-60 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-0645 | 67046-0645-03 |
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 5 mg/1 | TabletOral | APNAR PHARMA LP | 24689-781 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | APNAR PHARMA LP | 24689-785 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | APNAR PHARMA LP | 24689-907 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | APNAR PHARMA LP | 24689-921 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | APNAR PHARMA LP | 24689-933 |
| 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 |