Prescription drug · ANDA
Ziprasidone NDC 0904-6272
Ziprasidone hydrochloride 80 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6272-08 | 00904627208 | 40 BLISTER PACK in 1 CARTON (0904-6272-08) / 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 15, 2012 | |
| 0904-6272-45 | 00904627245 | 80 BLISTER PACK in 1 CARTON (0904-6272-45) / 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 15, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- ziprasidone
- Active ingredients
- Ziprasidone hydrochloride — 80 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077565
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6272_a7d74c6c-aacf-42bf-8b75-4acce832eb94SPL ID a7d74c6c-aacf-42bf-8b75-4acce832eb94SPL set ID ca55c149-5b9a-4144-b586-37cb5e84dc4eRxCUI 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
N400904627208followed by a unit qualifier and the quantityPackage 00904-6272-08. 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 0904-6272
- What is NDC 0904-6272?
- 0904-6272 is the product NDC for Ziprasidone, Ziprasidone hydrochloride 80 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ziprasidone.
- What is the active ingredient?
- Ziprasidone hydrochloride.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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?
- 19 other product NDCs are listed under this name. See all Ziprasidone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ziprasidone 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 | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4761 | 70518-4761-00 |
| ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4711 | 70518-4711-0070518-4711-02 |
| ziprasidone | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4709 | 70518-4709-0070518-4709-0270518-4709-03 |
| ziprasidone | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4475 | 70518-4475-0070518-4475-0170518-4475-03 |
| ziprasidone | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-835 | 16714-0835-01 |
| ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-836 | 16714-0836-01 |
| ziprasidone | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-837 | 16714-0837-01 |
| ziprasidone | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-838 | 16714-0838-01 |
| Ziprasidone | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-991 | 62135-0991-60 |
| Ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-992 | 62135-0992-60 |
Other NDCs under ANDA 077565
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 | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6269 |
| Ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6270 |
| Ziprasidone | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6271 |
| ziprasidone | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-835 |
| ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-836 |
| ziprasidone | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-837 |
| ziprasidone | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-838 |
| ziprasidone | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-256 |
| ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-257 |
| ziprasidone | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-258 |
| ziprasidone | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-259 |
| ziprasidone | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4475 |
| ziprasidone | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4709 |
| ziprasidone | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4711 |
| ziprasidone | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4761 |
| ziprasidone hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3418 |
| ziprasidone hydrochloride | Ziprasidone hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1835 |
| ziprasidone hydrochloride | Ziprasidone hydrochloride 80 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1508 |
| ziprasidone hydrochloride | Ziprasidone hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2236 |
| ziprasidone hydrochloride | Ziprasidone hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9761 |