Prescription drug · ANDA
Buspirone Hydrochloride (Buspirone) NDC 83209-554
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · Boswell Pharmacy Services d/b/a BPS Wholesale
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83209-554-15 | 83209055415 | 15 TABLET in 1 BLISTER PACK (83209-554-15)Marketed from May 15, 2024 | |
| 83209-554-21 | 83209055421 | 21 TABLET in 1 BLISTER PACK (83209-554-21)Marketed from May 15, 2024 | |
| 83209-554-30 | 83209055430 | 30 TABLET in 1 BLISTER PACK (83209-554-30)Marketed from May 15, 2024 | |
| 83209-554-60 | 83209055460 | 60 TABLET in 1 BLISTER PACK (83209-554-60)Marketed from May 15, 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
- Active ingredients
- Buspirone hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Boswell Pharmacy Services d/b/a BPS WholesaleNDC labeler code 83209
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075022
- Marketing start
- Listing expires
- Identifiers
- Product ID 83209-554_18e9092c-7992-80e0-e063-6294a90a73fbSPL ID 18e9092c-7992-80e0-e063-6294a90a73fbSPL set ID 18e90d65-4a3a-864e-e063-6294a90ae99dRxCUI 866083UNII 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
N483209055415followed by a unit qualifier and the quantityPackage 83209-0554-15. 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.
About NDC 83209-554
- What is NDC 83209-554?
- 83209-554 is the product NDC for Buspirone Hydrochloride (buspirone), Buspirone hydrochloride 10 mg/1 tablet, listed with the FDA by Boswell Pharmacy Services d/b/a BPS Wholesale. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buspirone Hydrochloride (Buspirone).
- What is the active ingredient?
- Buspirone hydrochloride.
- Who is the labeler?
- Boswell Pharmacy Services d/b/a BPS Wholesale, NDC labeler code 83209. 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?
- 259 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 | 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 2.5 mg/1 | TabletOral | IPG Pharmaceuticals, Inc | 71085-093 | 71085-0093-60 |
| Buspirone Hydrochloride | Buspirone hydrochloride 12.5 mg/1 | TabletOral | IPG Pharmaceuticals, Inc | 71085-094 | 71085-0094-30 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-0645 | 67046-0645-03 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4586 | 70518-4586-00 |
Other NDCs under ANDA 075022
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 | Teva Pharmaceuticals USA, Inc. | 0093-0053 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-0054 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1003 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-5200 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7689 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7714 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7718 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8527 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4862 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-5886 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6719 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-015 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Proficient Rx LP | 63187-402 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 63187-904 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Redpharm Drug | 67296-2276 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3881 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Proficient Rx LP | 71205-799 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0253 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1105 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2510 |
Showing 20 of 24.