Prescription drug · ANDA

ziprasidone NDC 55111-257

Ziprasidone hydrochloride 40 mg/1 · Capsule · Oral · Dr. Reddy's Laboratories Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)55111-257Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0257Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55111-257-015511102570155111025701100 CAPSULE in 1 BOTTLE (55111-257-01)Marketed from Mar 2, 2012
55111-257-055511102570555111025705500 CAPSULE in 1 BOTTLE (55111-257-05)Marketed from Mar 2, 2012
55111-257-30551110257305511102573030 CAPSULE in 1 BOTTLE (55111-257-30)Marketed from Mar 2, 2012
55111-257-60551110257605511102576060 CAPSULE in 1 BOTTLE (55111-257-60)Marketed from Mar 2, 2012
55111-257-78551110257785511102577810 BLISTER PACK in 1 CARTON (55111-257-78) / 10 CAPSULE in 1 BLISTER PACKMarketed from Mar 2, 2012
55111-257-8155111025781551110257813 BLISTER PACK in 1 CARTON (55111-257-81) / 10 CAPSULE in 1 BLISTER PACKMarketed from Mar 2, 2012
55111-257-90551110257905511102579090 CAPSULE in 1 BOTTLE (55111-257-90)Marketed from Mar 2, 2012

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
Generic name (nonproprietary)
ziprasidone
Active ingredients
Ziprasidone hydrochloride — 40 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077565
Marketing start
Listing expires
Identifiers
Product ID 55111-257_8c954cc0-a912-9c0a-93d9-9264d8a63c79SPL ID 8c954cc0-a912-9c0a-93d9-9264d8a63c79SPL set ID 396cb4a6-01a1-f73f-2a37-39df9067bf98RxCUI 313776, 313777, 313778, 314286UNII 216X081ORUUPC 0355111257608, 0355111256601
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

N455111025701 followed by a unit qualifier and the quantity

Package 55111-0257-01. 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 ventricular…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-257

What is NDC 55111-257?
55111-257 is the product NDC for ziprasidone, Ziprasidone hydrochloride 40 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 7 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?
Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other ziprasidone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ziprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-476170518-4761-00
ziprasidoneZiprasidone hydrochloride 40 mg/1CapsuleOralREMEDYREPACK INC.70518-471170518-4711-0070518-4711-02
ziprasidoneZiprasidone hydrochloride 80 mg/1CapsuleOralREMEDYREPACK INC.70518-470970518-4709-0070518-4709-0270518-4709-03
ziprasidoneZiprasidone hydrochloride 60 mg/1CapsuleOralREMEDYREPACK INC.70518-447570518-4475-0070518-4475-0170518-4475-03
ziprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC16714-83516714-0835-01
ziprasidoneZiprasidone hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC16714-83616714-0836-01
ziprasidoneZiprasidone hydrochloride 60 mg/1CapsuleOralNorthStar Rx LLC16714-83716714-0837-01
ziprasidoneZiprasidone hydrochloride 80 mg/1CapsuleOralNorthStar Rx LLC16714-83816714-0838-01
ZiprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralChartwell RX, LLC62135-99162135-0991-60
ZiprasidoneZiprasidone hydrochloride 40 mg/1CapsuleOralChartwell RX, LLC62135-99262135-0992-60

All 20 ziprasidone NDCs

Other NDCs under ANDA 077565

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077565
ProductStrengthForm · routeLabelerProduct NDC
ZiprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralMajor Pharmaceuticals0904-6269
ZiprasidoneZiprasidone hydrochloride 40 mg/1CapsuleOralMajor Pharmaceuticals0904-6270
ZiprasidoneZiprasidone hydrochloride 60 mg/1CapsuleOralMajor Pharmaceuticals0904-6271
ZiprasidoneZiprasidone hydrochloride 80 mg/1CapsuleOralMajor Pharmaceuticals0904-6272
ziprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC16714-835
ziprasidoneZiprasidone hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC16714-836
ziprasidoneZiprasidone hydrochloride 60 mg/1CapsuleOralNorthStar Rx LLC16714-837
ziprasidoneZiprasidone hydrochloride 80 mg/1CapsuleOralNorthStar Rx LLC16714-838
ziprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-256
ziprasidoneZiprasidone hydrochloride 60 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-258
ziprasidoneZiprasidone hydrochloride 80 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-259
ziprasidoneZiprasidone hydrochloride 60 mg/1CapsuleOralREMEDYREPACK INC.70518-4475
ziprasidoneZiprasidone hydrochloride 80 mg/1CapsuleOralREMEDYREPACK INC.70518-4709
ziprasidoneZiprasidone hydrochloride 40 mg/1CapsuleOralREMEDYREPACK INC.70518-4711
ziprasidoneZiprasidone hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-4761
ziprasidone hydrochlorideZiprasidone hydrochloride 20 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-3418
ziprasidone hydrochlorideZiprasidone hydrochloride 80 mg/1CapsuleOralBryant Ranch Prepack71335-1508
ziprasidone hydrochlorideZiprasidone hydrochloride 40 mg/1CapsuleOralBryant Ranch Prepack71335-2236
ziprasidone hydrochlorideZiprasidone hydrochloride 60 mg/1CapsuleOralBryant Ranch Prepack71335-9761

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