Prescription drug · ANDA
Buspirone Hydrochloride NDC 80425-0334
Buspirone hydrochloride 5 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0334-1 | 80425033401 | 30 TABLET in 1 BOTTLE (80425-0334-1)Marketed from May 19, 2023 | |
| 80425-0334-2 | 80425033402 | 60 TABLET in 1 BOTTLE (80425-0334-2)Marketed from May 19, 2023 | |
| 80425-0334-3 | 80425033403 | 90 TABLET in 1 BOTTLE (80425-0334-3)Marketed from May 19, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078246
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0334_2a9bad62-b308-697c-e063-6294a90aa395SPL ID 2a9bad62-b308-697c-e063-6294a90aa395SPL set ID fc0f93c8-2078-b2ff-e053-6294a90aacdfRxCUI 866094UNII 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
N480425033401followed by a unit qualifier and the quantityPackage 80425-0334-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 80425-0334
- What is NDC 80425-0334?
- 80425-0334 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 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 hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 078246
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 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-6188 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7075 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-389 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-390 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-391 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-392 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-393 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4317 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2073 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2081 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2193 |
| Buspirone Hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Proficient Rx LP | 82804-039 |