Prescription drug · ANDA
ziprasidone hydrochloride (Ziprasidone hcl) NDC 50268-814
Ziprasidone hydrochloride 80 mg/1 · Capsule · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-814-12 | 5026808141250268081412 | 20 BLISTER PACK in 1 BOX (50268-814-12) / 1 CAPSULE in 1 BLISTER PACK (50268-814-11)Marketed from May 12, 2021 |
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 — 80 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077561
- Marketing start
- Listing expires
- Identifiers
- Product ID 50268-814_4837897c-231e-1f6b-e063-6294a90a291cSPL ID 4837897c-231e-1f6b-e063-6294a90a291cSPL set ID c227a618-1274-2b4d-e053-2a95a90a74fbRxCUI 313776, 313777, 313778, 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
N450268081412followed by a unit qualifier and the quantityPackage 50268-0814-12. 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…
Excerpt only. Read the full label for complete information.
About NDC 50268-814
- What is NDC 50268-814?
- 50268-814 is the product NDC for ziprasidone hydrochloride (ziprasidone hcl), Ziprasidone hydrochloride 80 mg/1 capsule, listed with the FDA by AvPAK. It has 1 package NDC, 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?
- AvPAK, NDC labeler code 50268. 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 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 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0743 | 70518-0743-0070518-0743-0170518-0743-03 |
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 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 40 mg/1 | CapsuleOral | Proficient Rx LP | 63187-431 |
| 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 |