Prescription drug · ANDA
Ziprasidone Hydrochloride NDC 68001-453
Ziprasidone hydrochloride 80 mg/1 · Capsule · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-453-06 | 68001045306 | 60 CAPSULE in 1 BOTTLE (68001-453-06)Marketed from Aug 31, 2020 |
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)
- Ziprasidone Hydrochloride
- Generic name (nonproprietary)
- ziprasidone hydrochloride
- Active ingredients
- Ziprasidone hydrochloride — 80 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204117
- Marketing start
- Listing expires
- Identifiers
- Product ID 68001-453_326cdd3c-c314-ff98-e063-6294a90a2a20SPL ID 326cdd3c-c314-ff98-e063-6294a90a2a20SPL set ID c0eb7b4d-0264-4eed-8756-51bba3af82fbRxCUI 313776, 313777, 313778, 314286UNII 216X081ORUUPC 0368001450065
- Pharmacologic class
- Atypical Antipsychotic
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
N468001045306followed by a unit qualifier and the quantityPackage 68001-0453-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3) ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204117
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 |
|---|---|---|---|---|
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3563 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-451 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-452 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-705 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-702 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-703 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-704 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-450 |