NDC 16714-836 Ziprasidone Hydrochloride
|Color(s)||PURPLE (C48327 - LAVENDER OPAQUE CAP AND FLESH OPAQUE BODY) |
PURPLE (C48327 - LAVENDER OPAQUE CAP AND LT TURQUOISE BLUE OPAQUE BODY)
|Shape||CAPSULE (C48336) |
|Size(s)||14 MM |
NDC Code 16714-836-01
Package Description: 60 CAPSULE in 1 BOTTLE
Price per Unit: $0.30298 per EA
What is NDC 16714-836?
The NDC code 16714-836 is assigned by the FDA to the product Ziprasidone Hydrochloride which is a human prescription drug product labeled by Northstar Rx Llc. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 16714-836-01 60 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.
What are the uses for Ziprasidone Hydrochloride?
Ziprasidone hydrochloride 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 tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]SchizophreniaZiprasidone hydrochloride capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone hydrochloride capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone hydrochloride capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
What are Ziprasidone Hydrochloride Active Ingredients?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are Ziprasidone Hydrochloride UNII Codes?
The UNII codes for the active ingredients in this product are:
- ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU)
- ZIPRASIDONE (UNII: 6UKA5VEJ6X) (Active Moiety)
Which are Ziprasidone Hydrochloride Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POVIDONE K30 (UNII: U725QWY32X)
- STARCH, CORN (UNII: O8232NY3SJ)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
- GELATIN (UNII: 2G86QN327L)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
- ALCOHOL (UNII: 3K9958V90M)
- ISOPROPYL ALCOHOL (UNII: ND2M416302)
- POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- AMMONIA (UNII: 5138Q19F1X)
What is the NDC to RxNorm Crosswalk for Ziprasidone Hydrochloride?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 313776 - ziprasidone HCl 40 MG Oral Capsule
- RxCUI: 313776 - ziprasidone 40 MG Oral Capsule
- RxCUI: 313776 - ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral Capsule
- RxCUI: 313777 - ziprasidone HCl 60 MG Oral Capsule
- RxCUI: 313777 - ziprasidone 60 MG Oral Capsule
Which are the Pharmacologic Classes for Ziprasidone Hydrochloride?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the disclaimer below.
Ziprasidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Ziprasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
* Please review the disclaimer below.
We have moved the product label and warning information to a dedicated page, please follow the link below:View Product Label