Prescription drug · ANDA
Buspirone Hydrochloride NDC 71085-094
Buspirone hydrochloride 12.5 mg/1 · Tablet · Oral · IPG Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71085-094-30 | 7108500943071085009430 | 30 TABLET in 1 BOTTLE (71085-094-30)Marketed from May 29, 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)
- Buspirone Hydrochloride
- Generic name (nonproprietary)
- buspirone hydrochloride
- Active ingredients
- Buspirone hydrochloride — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- IPG Pharmaceuticals, IncNDC labeler code 71085
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208972
- Marketing start
- Listing expires
- Identifiers
- Product ID 71085-094_54ce3b90-d11a-cd1e-e063-6294a90a2753SPL ID 54ce3b90-d11a-cd1e-e063-6294a90a2753SPL set ID 2c516eec-65d9-4481-8823-ae6b6da84062RxCUI 2744290, 2744292UNII 207LT9J9OCUPC 0371085093608, 0371085094308
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
N471085009430followed by a unit qualifier and the quantityPackage 71085-0094-30. 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 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 71085-094
- What is NDC 71085-094?
- 71085-094 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 12.5 mg/1 tablet, listed with the FDA by IPG Pharmaceuticals, Inc. 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?
- IPG Pharmaceuticals, Inc, NDC labeler code 71085. 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 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 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4586 | 70518-4586-00 |
Other NDCs under ANDA 208972
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 | Epic Pharma, LLC | 42806-082 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Epic Pharma, LLC | 42806-083 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Epic Pharma, LLC | 42806-084 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Epic Pharma, LLC | 42806-085 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Epic Pharma, LLC | 42806-086 |
| Buspirone Hydrochloride | Buspirone hydrochloride 2.5 mg/1 | TabletOral | IPG Pharmaceuticals, Inc | 71085-093 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-404 |