Prescription drug · ANDA
buspirone hydrochloride NDC 65841-783
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-783-01 | 65841078301 | 100 TABLET in 1 BOTTLE (65841-783-01)Marketed from May 3, 2014 | |
| 65841-783-05 | 65841078305 | 500 TABLET in 1 BOTTLE (65841-783-05)Marketed from May 3, 2014 | |
| 65841-783-10 | 65841078310 | 1000 TABLET in 1 BOTTLE (65841-783-10)Marketed from May 3, 2014 | |
| 65841-783-14 | 65841078314 | 60 TABLET in 1 BOTTLE (65841-783-14)Marketed from May 3, 2014 | |
| 65841-783-28 | 65841078328 | 180 TABLET in 1 BOTTLE (65841-783-28)Marketed from May 3, 2014 | |
| 65841-783-77 | 65841078377 | 100 BLISTER PACK in 1 CARTON (65841-783-77) / 1 TABLET in 1 BLISTER PACK (65841-783-30)Marketed from May 3, 2014 |
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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078888
- Marketing start
- Listing expires
- Identifiers
- Product ID 65841-783_0ea86a43-52f7-4fad-acda-a4625f4280a2SPL ID 0ea86a43-52f7-4fad-acda-a4625f4280a2SPL set ID 1109dd63-6492-49b1-a383-3ab3a80cd6c7RxCUI 866018, 866083, 866090, 866094, 866111UNII 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
N465841078301followed by a unit qualifier and the quantityPackage 65841-0783-01. 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
Current FDA label (SPL), effective .
Other NDCs under ANDA 078888
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 | Cardinal Health 107, LLC | 55154-3364 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2199 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-019 |
| buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-781 |
| buspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-782 |
| buspirone hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-784 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-623 |
| buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-842 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3906 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-206 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | AvPAK | 50268-135 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2237 |
| Buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-266 |
| Buspirone hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-183 |
| Buspirone hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-180 |
| Buspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-181 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-182 |
| Buspirone hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6899 |
| Buspirone hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0222 |
| Buspirone hydrochloride | Buspirone hydrochloride 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2820 |
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