Prescription drug · ANDA
Buspirone Hydrochloride NDC 76420-809
Buspirone hydrochloride 15 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-809-01 | 76420080901 | 100 TABLET in 1 BOTTLE, PLASTIC (76420-809-01)Marketed from May 6, 2024 | |
| 76420-809-05 | 76420080905 | 500 TABLET in 1 BOTTLE, PLASTIC (76420-809-05)Marketed from May 6, 2024 | |
| 76420-809-18 | 76420080918 | 180 TABLET in 1 BOTTLE, PLASTIC (76420-809-18)Marketed from May 6, 2024 | |
| 76420-809-30 | 76420080930 | 30 TABLET in 1 BOTTLE, PLASTIC (76420-809-30)Marketed from May 6, 2024 | |
| 76420-809-60 | 76420080960 | 60 TABLET in 1 BOTTLE, PLASTIC (76420-809-60)Marketed from May 6, 2024 | |
| 76420-809-90 | 76420080990 | 90 TABLET in 1 BOTTLE, PLASTIC (76420-809-90)Marketed from May 6, 2024 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210907
- Marketing start
- Listing expires
- Identifiers
- Product ID 76420-809_5100f189-0915-07b9-e063-6394a90acd18SPL ID 5100f189-0915-07b9-e063-6394a90acd18SPL set ID 97f2d082-0931-4e4f-a5be-7792e399e42bRxCUI 866018, 866083, 866090, 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
N476420080901followed by a unit qualifier and the quantityPackage 76420-0809-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Buspirone hydrochloride tablets, USP 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, USP 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, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evalua…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210907
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 | NuCare Pharmaceuticals,Inc. | 68071-2987 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2995 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8086 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-020 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-018 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-7652 |
| Buspirone HCL | Buspirone hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-448 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-724 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0505 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-725 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3279 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-245 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-7161 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-244 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-0645 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2458 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-246 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-247 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0303 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1924 |
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