Prescription drug · ANDA
Buspirone Hydrochloride NDC 42806-833
Buspirone 15 mg/1 · Capsule · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-833-18 | 4280608331842806083318 | 180 CAPSULE in 1 BOTTLE (42806-833-18)Marketed from Mar 13, 2025 | |
| 42806-833-60 | 4280608336042806083360 | 60 CAPSULE in 1 BOTTLE (42806-833-60)Marketed from Mar 13, 2025 |
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 — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- EPIC PHARMA, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218628
- Marketing start
- Listing expires
- Identifiers
- Product ID 42806-833_160f52d2-2e08-4969-80c3-c653767652f0SPL ID 160f52d2-2e08-4969-80c3-c653767652f0SPL set ID 160f52d2-2e08-4969-80c3-c653767652f0RxCUI 2708991, 2708993, 2708994UNII TK65WKS8HLUPC 0342806832011
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
N442806083318followed by a unit qualifier and the quantityPackage 42806-0833-18. 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 capsules 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 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had exper…
Excerpt only. Read the full label for complete information.
About NDC 42806-833
- What is NDC 42806-833?
- 42806-833 is the product NDC for Buspirone Hydrochloride, Buspirone 15 mg/1 capsule, listed with the FDA by EPIC PHARMA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buspirone Hydrochloride.
- What is the active ingredient?
- Buspirone.
- Who is the labeler?
- EPIC PHARMA, LLC, NDC labeler code 42806. 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 218628
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 |
|---|---|---|---|---|
| Bucapsolbuspirone hydrochloride | Buspirone 5 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-121 |
| Bucapsolbuspirone hydrochloride | Buspirone 7.5 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-122 |
| Bucapsolbuspirone hydrochloride | Buspirone 10 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-123 |
| Bucapsolbuspirone hydrochloride | Buspirone 15 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-124 |
| Buspirone Hydrochloride | Buspirone 7.5 mg/1 | CapsuleOral | EPIC PHARMA, LLC | 42806-831 |
| Buspirone Hydrochloride | Buspirone 10 mg/1 | CapsuleOral | EPIC PHARMA, LLC | 42806-832 |