Prescription drug · ANDA
Ziprasidone Hydrochloride NDC 63629-8150
Ziprasidone hydrochloride 20 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8150-1 | 63629815001 | 30 CAPSULE in 1 BOTTLE (63629-8150-1)Marketed from Apr 3, 2024 | |
| 63629-8150-2 | 63629815002 | 60 CAPSULE in 1 BOTTLE (63629-8150-2)Marketed from Jun 18, 2019 |
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)
- Ziprasidone Hydrochloride
- Generic name (nonproprietary)
- ziprasidone hydrochloride
- Active ingredients
- Ziprasidone hydrochloride — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204375
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-8150_ea2b746e-ebf2-4ae2-9921-06b28cb310edSPL ID ea2b746e-ebf2-4ae2-9921-06b28cb310edSPL set ID 550aca3a-5051-432e-9a3f-a2e53cbd603dRxCUI 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
N463629815001followed by a unit qualifier and the quantityPackage 63629-8150-01. 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 . 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 ventricula…
Excerpt only. Read the full label for complete information.
About NDC 63629-8150
- What is NDC 63629-8150?
- 63629-8150 is the product NDC for Ziprasidone Hydrochloride, Ziprasidone hydrochloride 20 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ziprasidone Hydrochloride.
- What is the active ingredient?
- Ziprasidone hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 43 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 hydrochlorideziprasidone hcl | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | AvPAK | 50268-814 | 50268-0814-12 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-450 | 68001-0450-06 |
| 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 | REMEDYREPACK INC. | 70518-1835 | 70518-1835-00 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0787 | 70518-0787-0070518-0787-01 |
Other NDCs under ANDA 204375
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 20 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-144 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-145 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-146 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-147 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5420 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-3331 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0743 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0782 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0787 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0501 |
| Ziprasidone Hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0585 |