Prescription drug · ANDA
Bucapsol (Buspirone hydrochloride) NDC 81279-122
Buspirone 7.5 mg/1 · Capsule · Oral · PANGEA PHARMACEUTICALS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81279-122-30 | 8127901223081279012230 | 30 CAPSULE in 1 BOTTLE (81279-122-30)Marketed from Apr 10, 2026 | |
| 81279-122-60 | 8127901226081279012260 | 60 CAPSULE in 1 BOTTLE (81279-122-60)Marketed from Apr 10, 2026 |
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)
- Bucapsol
- Generic name (nonproprietary)
- buspirone hydrochloride
- Active ingredients
- Buspirone — 7.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PANGEA PHARMACEUTICALS, LLCNDC labeler code 81279
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218628
- Marketing start
- Listing expires
- Identifiers
- Product ID 81279-122_567c6ee6-d0ba-d324-e063-6294a90a3238SPL ID 567c6ee6-d0ba-d324-e063-6294a90a3238SPL set ID f101c5f3-d533-474d-a8bf-90d054933d16RxCUI 2708991, 2708993, 2708994, 2714180, 2714182, 2714184, 2747227, 2747229UNII TK65WKS8HLUPC 0381279122304, 0381279123301, 0381279121604, 0381279124308, 0381279122601, 0381279123608, 0381279121307, 0381279124605
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
N481279012230followed by a unit qualifier and the quantityPackage 81279-0122-30. 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 Bucapsol TM 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 experienced sympt…
Excerpt only. Read the full label for complete information.
About NDC 81279-122
- What is NDC 81279-122?
- 81279-122 is the product NDC for Bucapsol (buspirone hydrochloride), Buspirone 7.5 mg/1 capsule, listed with the FDA by PANGEA PHARMACEUTICALS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bucapsol (Buspirone Hydrochloride).
- What is the active ingredient?
- Buspirone.
- Who is the labeler?
- PANGEA PHARMACEUTICALS, LLC, NDC labeler code 81279. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bucapsol?
- 3 other product NDCs are listed under this name. See all Bucapsol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bucapsol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bucapsolbuspirone hydrochloride | Buspirone 5 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-121 | 81279-0121-3081279-0121-60 |
| Bucapsolbuspirone hydrochloride | Buspirone 10 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-123 | 81279-0123-3081279-0123-60 |
| Bucapsolbuspirone hydrochloride | Buspirone 15 mg/1 | CapsuleOral | PANGEA PHARMACEUTICALS, LLC | 81279-124 | 81279-0124-3081279-0124-60 |
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 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 |
| Buspirone Hydrochloride | Buspirone 15 mg/1 | CapsuleOral | EPIC PHARMA, LLC | 42806-833 |