Prescription drug · ANDA
Buspirone Hydrochloride NDC 68788-8086
Buspirone hydrochloride 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8086-1 | 6878880860168788808601 | 100 TABLET in 1 BOTTLE, PLASTIC (68788-8086-1)Marketed from Oct 5, 2021 | |
| 68788-8086-3 | 6878880860368788808603 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-8086-3)Marketed from Oct 5, 2021 | |
| 68788-8086-6 | 6878880860668788808606 | 60 TABLET in 1 BOTTLE, PLASTIC (68788-8086-6)Marketed from Oct 5, 2021 | |
| 68788-8086-9 | 6878880860968788808609 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-8086-9)Marketed from Oct 5, 2021 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210907
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-8086_c98271e1-13bb-44a2-bdb1-22e6d682450cSPL ID c98271e1-13bb-44a2-bdb1-22e6d682450cSPL set ID 068ee1a0-a77a-4803-bad9-18117d7fb358RxCUI 866083UNII 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
N468788808601followed by a unit qualifier and the quantityPackage 68788-8086-01. 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.
About NDC 68788-8086
- What is NDC 68788-8086?
- 68788-8086 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 12.5 mg/1 | TabletOral | IPG Pharmaceuticals, Inc | 71085-094 | 71085-0094-30 |
| 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 |
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 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-020 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-244 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7952 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1673 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7968 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-245 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3834 |
| Buspirone Hydrochloride | Buspirone hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3686 |
| 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 5 mg/1 | TabletOral | Proficient Rx LP | 82804-062 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2987 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2576 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-7161 |
| Buspirone Hydrochloride | Buspirone hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 82804-104 |
| Buspirone Hydrochloride | Buspirone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1749 |
| Buspirone HCL | Buspirone hydrochloride 15 mg/1 | TabletOral | Direct_Rx | 72189-620 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2060 |
| Buspirone HCL | Buspirone hydrochloride 5 mg/1 | TabletOral | Direct_Rx | 72189-628 |
| Buspirone Hydrochloride | Buspirone hydrochloride 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-724 |
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