Prescription drug · ANDA
ziprasidone hydrochloride (Ziprasidone hcl) NDC 63187-431
Ziprasidone hydrochloride 40 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-431-30 | 6318704313063187043130 | 30 CAPSULE in 1 BOTTLE (63187-431-30)Marketed from Feb 2, 2015 | |
| 63187-431-60 | 6318704316063187043160 | 60 CAPSULE in 1 BOTTLE (63187-431-60)Marketed from Feb 2, 2015 | |
| 63187-431-90 | 6318704319063187043190 | 90 CAPSULE in 1 BOTTLE (63187-431-90)Marketed from Feb 2, 2015 |
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 hcl
- Active ingredients
- Ziprasidone hydrochloride — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077561
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-431_a5b55c92-dad3-4edd-a80b-becf1c4acc9fSPL ID a5b55c92-dad3-4edd-a80b-becf1c4acc9fSPL set ID f60b6892-a437-450d-906a-978272148febRxCUI 313776, 314286UNII 216X081ORU
- 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
N463187043130followed by a unit qualifier and the quantityPackage 63187-0431-30. 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 hydrochloride capsules are indicated for the treatment of schizophrenia. 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 (5.2) ]. 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 tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause tor…
Excerpt only. Read the full label for complete information.
About NDC 63187-431
- What is NDC 63187-431?
- 63187-431 is the product NDC for ziprasidone hydrochloride (ziprasidone hcl), Ziprasidone hydrochloride 40 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ziprasidone hydrochloride (Ziprasidone HCl).
- What is the active ingredient?
- Ziprasidone hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ziprasidone hydrochloride?
- 44 other product NDCs are listed under this name. See all ziprasidone hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ziprasidone 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) |
|---|---|---|---|---|---|
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | AvPAK | 50268-814 | 50268-0814-12 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | AvPAK | 50268-811 | 50268-0811-12 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | AvPAK | 50268-812 | 50268-0812-12 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | AvPAK | 50268-813 | 50268-0813-12 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-451 | 68001-0451-06 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-452 | 68001-0452-06 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-453 | 68001-0453-06 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-450 | 68001-0450-06 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0787 | 70518-0787-0070518-0787-01 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0782 | 70518-0782-0170518-0782-03 |
Other NDCs under ANDA 077561
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 hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | AvPAK | 50268-811 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | AvPAK | 50268-812 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | AvPAK | 50268-813 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | AvPAK | 50268-814 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-765 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-766 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-767 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-768 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Apotex Corp. | 60505-2528 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Apotex Corp. | 60505-2529 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Apotex Corp. | 60505-2530 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Apotex Corp. | 60505-2531 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Proficient Rx LP | 63187-448 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Proficient Rx LP | 63187-578 |
| ziprasidone hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-6916 |
| Ziprasidone Hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | American Health Packaging | 68084-103 |
| Ziprasidone Hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | American Health Packaging | 68084-104 |
| Ziprasidone Hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | American Health Packaging | 68084-105 |
| Ziprasidone Hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | American Health Packaging | 68084-106 |