Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate
Rising Pharmaceuticals, Inc.
Human Prescription Drug
NDC 64980-104Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate is a human prescription drug labeled by 'Rising Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate is 64980-104. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate drug includes Potassium Phosphate, Monobasic - 155 mg/1 Sodium Phosphate, Dibasic, Anhydrous - 852 mg/1 Sodium Phosphate, Monobasic, Monohydrate - 130 mg/1 . The currest status of Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate drug is Active.
Drug Information:
| Drug NDC: | 64980-104 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And Monobasic Sodium Phosphate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rising Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POTASSIUM PHOSPHATE, MONOBASIC - 155 mg/1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS - 852 mg/1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - 130 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 28 Jun, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rising Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 200251
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 4J9FJ0HL51
22ADO53M6F
593YOG76RN
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 64980-104-01 | 100 TABLET in 1 BOTTLE (64980-104-01) | 28 Jun, 2012 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Dibasic sodium phosphate, monobasic potassium phosphate and monobasic sodium phosphate dibasic sodium phosphate, monobasic potassium phosphate and monobasic sodium phosphate sodium phosphate, dibasic, anhydrous phosphate ion potassium phosphate, monobasic phosphate ion sodium phosphate, monobasic, monohydrate phosphate ion water lactose monohydrate sodium starch glycolate type a potato povidone k30 magnesium stearate hypromellose 2910 (15000 mpa.s) polyethylene glycol 400 titanium dioxide ris;104
Drug Interactions:
Drug interactions: the use of antacids containing magnesium, aluminum, or calcium in conjunction with phosphate preparations may bind the phosphate and preventits absorption. concurrent use of antihypertensives, especially diazoxide, guanethidine, hydralazine, methyldopa, or rauwolfia alkaloid; or corticosteroids, especially mineralocorticoids or corticotropin with sodium phosphate may result in hypernatremia. calcium-containing preparations and/or vitamin d may antagonize the effects of phosphates in the treatment of hypercalcemia. potassium-containing medication or potassium-sparing diuretics may cause hyperkalemia. patients should have serum potassium level determinations at periodic intervals.
Indications and Usage:
Indications and usage phospha 250 tm neutral increases urinary phosphate and pyrophosphate. as a phosphorus supplement, each tablet supplies 25% of the u.s. recommended daily allowance (u.s. rda) of phosphorus for adults and children over 4 years of age.
General Precautions:
General: this product contains potassium and sodium and should be used with caution if regulation of these elements is desired. occasionally, some individuals may experience a mild laxative effect during the first few days of phosphate therapy. if laxation persists to an unpleasant degree reduce the daily dose until this effect subsides or, if necessary, discontinue the use of the product. caution should be exercised when prescribing this product in the following conditions: cardiac disease (particularly in digitalized patients); severe adrenal insufficiency (addison's disease); acute dehydration; severe renal insufficiency; renal function impairment or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; cardiac failure; cirrhosis of the liver or severe hepatic disease; peripheral or pulmonary edema; hypernatremia; hypertension; toxemia of pregnancy; hypoparathyroidism; and acute pancreatitis. rickets may benefit from phosphate therapy, but cau
Read more...tion should be exercised. high serum phosphate levels may increase the incidence of extraskeletal calcification.
Dosage and Administration:
Dosage and administration phospha 250 tm neutral tablets should be taken with a full glass of water, with meals and at bedtime. adults: one or two tablets, four times daily; pediatric patients over 4 years of age: one tablet four times daily. pediatric patients under 4 years of age: use only as directed by physician.
Contraindications:
Contraindications this product is contraindicated in patients with infected phosphate stones, in patients with severely impaired renal function (less than 30% of normal) and in the presence of hyperphosphatemia.
Adverse Reactions:
Adverse reactions: gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with phosphate therapy. also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. the following adverse effects may be observed (primarily from sodium or potassium): headaches; dizziness; mental confusion; seizures; weakness or heaviness of legs; unusual tiredness or weakness; muscle cramps; numbness, tingling, pain or weakness of hands or feet; numbness or tingling around lips; fast or irregular heartbeat; shortness of breath or troubled breathing; swelling of feet or lower legs; unusual weight gain; low urine output; unusual thirst. to report suspected adverse reactions, contact ingenus pharmaceuticals, llc at 1-877-748-1970 or fda at 1-800-fda-1088 or www.fda.gov/medwatch
Drug Interactions:
Drug interactions: the use of antacids containing magnesium, aluminum, or calcium in conjunction with phosphate preparations may bind the phosphate and preventits absorption. concurrent use of antihypertensives, especially diazoxide, guanethidine, hydralazine, methyldopa, or rauwolfia alkaloid; or corticosteroids, especially mineralocorticoids or corticotropin with sodium phosphate may result in hypernatremia. calcium-containing preparations and/or vitamin d may antagonize the effects of phosphates in the treatment of hypercalcemia. potassium-containing medication or potassium-sparing diuretics may cause hyperkalemia. patients should have serum potassium level determinations at periodic intervals.
Use in Pregnancy:
Pregnancy: teratogenic effects. pregnancy class c. animal reproduction studies have not been conducted with phospha 250 tm neutral. it is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. this product should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use: see dosage and administration .
Description:
Description each tablet contains 852 mg dibasic sodium phosphate anhydrous, 155 mg monobasic potassium phosphate, and 130 mg monobasic sodium phosphate monohydrate. each tablet yields approximately 250 mg of phosphorus, 298 mg of sodium (13.0 meq) and 45 mg of potassium (1 .1 meq).
Clinical Pharmacology:
Clinical pharmacology phosphorus has a number of important functions in the biochemistry of the body. the bulk of the body's phosphorus is located in the bones, where it plays a key role in osteoblastic and osteoclastic activities. enzymatically catalyzed phosphate-transfer reactions are numerous and vital in the metabolism of carbohydrate, lipid and protein, and a proper concentration of the anion is of primary importance in assuring an orderly biochemical sequence. ln addition, phosphorus plays an important rolein modifying steady-state tissue concentrations of calcium. phosphate ions are important buffers of the intracellular fluid, and also play a primary role in the renal excretionof the hydrogen ion. oral administration of inorganic phosphates increases serum phosphate levels. phosphates lower urinary calcium levels in idiopathic hypercalciuria. in general, in adults, about two thirds of the ingested phosphate in absorbed from the bowel, most of which is rapidly excreted into the
Read more... urine.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: no long term or reproduction studies in animals or humans have been performed with phospha 250 tm neutral to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.
How Supplied:
How supplied white, film-coated, capsule-shaped tablet, debossed with ris 104 on each tablet. ndc #64980-104-01 bottles of 100 tablets
Information for Patients:
Information for patients: patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. patients should be advised to avoid the use of antacids containing aluminum, magnesium, or calcium which may prevent the absorption of phosphate.
Package Label Principal Display Panel:
Package label.principal display - 250 mg rising ® ndc 64980-104-01 phospha 250 tm neutral phosphourus supplement which supplies 250 mg per tablet 100 tablets rx only phospha-250-neutral-100ct-label