Home › NDC Lookup › Ingredients › Monobasic Sodium Phosphate And Dibasic S... › 43386-0030-01
⚪image loading
(from DailyMed)

Monobasic Sodium Phosphate and Dibasic 1.105 g; .398 g Tablet, 100-count — NDC 43386-030-01 (Billing 43386-0030-01)

by Lupin Pharmaceuticals,Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Monobasic Sodium Phosphate and Dibasic 1.105 g; .398 g Tablet from Lupin Pharmaceuticals,Inc., marketed since Jan 2012 and currently FDA-listed. It is this product's only package size.

NDC 43386-0030-01
🏷️ FDA NDC (as labeled) 43386-030-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43386-030-01
Product NDC 43386-030
11-digit billing NDC 43386003001
UNII 593YOG76RN, 22ADO53M6F
UPC 0343386030019
Application # ANDA079247
SPL Set ID e2fcc382-6fac-4438-ad02-ebc8528dd59a
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-01-20
Route ORAL
Dosage form TABLET
Substance SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Why two NDCs? The FDA registers this code as 43386-030-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0030-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43386-0030-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2012-01-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate 1.105 g/1; .398 gthis 43386-0030-01 Lupin 100 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2012
On the market since
Jan 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeOval
ImprintN;03
Size18 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLupin Pharmaceuticals,Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA079247 (ANDA)
Labeler code43386
First marketedJan 2012
Product typeHuman Prescription Drug
Portfolio89 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

BOXED WARNING WARNING: ACUTE PHOSPHATE NEPHROPATHY There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis [see Warnings and Precautions ( 5.1 )] . While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions ( 5.1 )].

Advise patients of the importance of following the recommended split dosage regimen and the importance of adequate hydration before, during and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Avoid additional sodium phosphate- based purgative or enema products [see Dosage and Administration ( 2.1 , 2.2 )] . WARNING: ACUTE PHOSPHATE NEPHROPATHY See full prescribing information for complete boxed warning.

Rare, serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. ( 5.1 ) Patients at increased risk include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]) .

( 5.1 ) Advise patients of the importance of following the recommended split dosage regimen and the importance of adequate hydration before, during and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Avoid additional sodium phosphate-based products. ( 2.1 , 2.2 )

🎯 Indications and Usage 51 words ▾

1 INDICATIONS AND USAGE Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Important Administration Instructions: Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are required for a complete preparation for colonoscopy: the first dose the evening before the colonoscopy and the second dose on the morning of the colonoscopy. ( 2.1 ) Do not take other laxatives, particularly additional sodium phosphate- based purgative or enema products. ( 2.1 , 7.3 ) Do not take oral medications within 1 hour before or after starting each dose.

( 2.1 , 7.2 ) Dosage Regimen ( 2.2 ) The recommended adult dosage is 32 tablets taken orally with a total of 2 quarts of clear liquids in the following manner: Evening before colonoscopy: 4 tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets. Next morning: 4 tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets.

2.1Important Administration Instructions Correct fluid and electrolyte abnormalities before treatment with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [ see Warnings and Precautions (5.1) ] . Clear liquids must be consumed before, during and after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ] . Do not administer Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets within 7 days of a previous use.

Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are required for a complete preparation for colonoscopy: the first dose the evening before the colonoscopy and the second dose on the morning of the colonoscopy [see Dosage and Administration (2.2) ]. Consume only clear liquids (no solid food) from the start of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets treatment until after the colonoscopy. Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.

Do not take other laxatives while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, particularly additional sodium phosphate-based purgative or enema products [see Drug Interactions (7.3) ] . Do not take oral medications within 1 hour before or after starting each dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Drug Interactions (7.2) ] .

2.2Dosage Regimen Instruct adult patients that on the day before their colonoscopy, they can consume a light breakfast consisting of clear soup and/or plain yogurt (no solid foods) before noon, followed by only clear liquids until after the colonoscopy. The recommended dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets for colon cleansing for adult patients is 32 tablets (48 grams of sodium phosphate) taken orally with a total of 2 quarts of clear liquids in the following manner: The evening before the colonoscopy : Take 4 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets.

On the day of the colonoscopy starting 3 to 5 hours before the procedure : Take 4 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets.

💊 Dosage Forms and Strengths 106 words ▾

3 DOSAGE FORMS AND STRENGTHS Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are supplied as white to off-white uncoated tablet, modified oval shaped, biconvex, bisect on one side and plain on the other. Debossed "N" on the left side of the bisect and "03" on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets contains 1.102 grams of Monobasic Sodium Phosphate, USP and 0.398 grams of Dibasic Sodium Phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet.

Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. Tablets: 1.5 g of sodium phosphate (3)

⛔ Contraindications 132 words ▾

4 CONTRAINDICATIONS Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are contraindicated in the following conditions: History of acute phosphate nephropathy [see Warnings and Precautions (5.1) ] Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.7) ] Gastric bypass or stapling surgery Bowel perforation Toxic colitis Toxic megacolon Hypersensitivity to sodium phosphate salts or any component of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Warnings and Precautions (5.7) ].

Biopsy-proven acute phosphate nephropathy ( 4 , 5.1 ) Gastrointestinal (GI) obstruction ( 4 , 5.7 ) Gastric bypass or stapling surgery ( 4 ) Bowel perforation ( 4 ) Toxic colitis ( 4 ) Toxic megacolon ( 4 ) Hypersensitivity to sodium phosphate salts or any components of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets ( 4 , 5.7 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Renal disease and electrolyte disorders : Use caution in severe renal impairment and those taking concurrent medications that increase risk, ensure adequate hydration, and consider laboratory assessments prior to and after use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.

( 5.3 , 7.1 ) Suspected GI obstruction or perforation : Rule out diagnosis before administration. ( 4 , 5.4 ) Colonic mucosal ulceration : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Use with caution in patients with an acute exacerbation of chronic inflammatory bowel disease ( 5.5 ) Patients at risk for aspiration : Observe during administration.

( 5.6 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. ( 5.7 )

5.1Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders Renal Disease and Acute Phosphate Nephropathy There have been rare, but serious, reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis.

The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.1) ] .

Electrolyte Disorders Bowel preparations, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tabletscan cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures and renal impairment [see Adverse Reactions (6.2) ] . Patient Management Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are contraindicated in patients with a history of acute phosphate nephropathy [see Contraindications (4) ]. Use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 mL/minute), with conditions, or who are taking medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of arrhythmias, seizures, or renal impairment.

Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Drug Interactions (7.1) ] . Correct electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia before treatment with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Dosage and Administration (2.1) ] . Avoid additional sodium phosphate-based purgative or enema products [see Drug Interactions (7.1) ] .

Advise all patients to hydrate adequately before, during, and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Dosage and Administration (2.1,2.2) ] . If a patient develops significant vomiting or signs of dehydration while or after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, consider performing post-colonoscopy lab tests [electrolytes, creatinine, and blood u… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders [see Warnings and Precautions (5.1) ] Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.3) ] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.4) ] Colonic Mucosal Ulceration and Inflammatory Bowel Disease [see Warnings and Precautions (5.5) ] Aspiration [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥3%) are: bloating, nausea, abdominal pain, and vomiting.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy. The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female [see Clinical Studies (14) ] .

Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1 [see Clinical Studies (14) ]. Since diarrhea was considered as a part of the efficacy of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, diarrhea was not defined as an adverse event in this clinical trial. 1 Reported in more than 3% of patients in at least one treatment group 2 Another oral formulation of monobasic sodium phosphate and dibasic sodium phosphate Table 1: Common Adverse Reactions 1 in Patients Undergoing Colonoscopy in Study 1 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 32 tabs (48 g) N=272 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 40 tabs (60 g) N=265 Sodium Phosphate2 40 tabs (60 g) N=268 Bloating 31% 39% 41% Nausea 26% 37% 30% Abdominal Pain 23% 24% 25% Vomiting 4% 10% 9% Electrolyte Abnormalities in Study 1 Hyperphosphatemia A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy.

In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy. Hyperkalemia A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy.

In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy. Seve… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 201 words ▾

7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. ( 7.1 ) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

7.1Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate in patients taking these concomitant medications [see Warnings and Precautions (5.1,5.2,5.3) ] .

7.2Potential for Reduced Drug Absorption Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets can reduce the absorption of other coadministered oral medications. Administer oral medications at least 1 hour before or 1 hour after starting each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dose [see Dosage and Administration (2.1) ] .

7.3Other Sodium Phosphate-Based Laxatives Administration of additional sodium phosphate-based purgative or enema products with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets may increase the risk of acute phosphate nephropathy. Avoid concomitant use [see Warnings and Precautions (5.1) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with sodium phosphate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary There are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets and any potential adverse effects on the breastfed child from Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Of the 599 patients in clinical trials receiving at least 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets administration.

The mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dosage regimen in Study 1were 7.0, 7.3, and 8.0 mg/dL, respectively. After Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dL, respectively. Greater sensitivity of some older individuals cannot be ruled out; therefore, use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with caution in geriatric patients.

Advise geriatric patients to adequately hydrate before, during, and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. Since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Warnings and Precautions (5.1) ].

8.6Renal Impairment Sodium phosphate is substantially excreted by the kidney. Use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury.

Advise these patients of the importance of adequate hydration before, during and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] .

🤰 Pregnancy 93 words ▾

8.1Pregnancy Risk Summary There are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with sodium phosphate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 599 patients in clinical trials receiving at least 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets administration.

The mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dosage regimen in Study 1were 7.0, 7.3, and 8.0 mg/dL, respectively. After Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dL, respectively. Greater sensitivity of some older individuals cannot be ruled out; therefore, use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with caution in geriatric patients.

Advise geriatric patients to adequately hydrate before, during, and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. Since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Warnings and Precautions (5.1) ].

🆘 Overdosage 73 words ▾

10 OVERDOSAGE Overdosage of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets may lead to severe electrolyte disturbances, including hyperphosphatemia, hypocalcemia, hypernatremia, or hypokalemia, as well as dehydration and hypovolemia, with attendant signs and symptoms of these disturbances. Certain severe electrolyte disturbances resulting from overdose may lead to cardiac arrhythmias, seizure, renal failure, and death [see Warnings and Precautions (5.1, 5.2, 5.3) ] . Monitor for fluid and electrolyte disturbances and treated symptomatically.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary mode of action is the osmotic effect of sodium, which induces a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

12.2Pharmacodynamics Administration of the recommended Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dosage regimen has a purgative effect for approximately 1 to 3 hours.

12.3Pharmacokinetics Pharmacokinetic studies with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets have not been conducted. However, the following pharmacokinetic study was conducted with another oral tablet formulation of sodium phosphate which contain the same active ingredients as Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets at a dose that is 25% greater than the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dose. Absorption An open-label pharmacokinetic study of oral sodium phosphate in healthy subjects was performed to determine the concentration-time profile of serum inorganic phosphorus levels after oral sodium phosphate administration.

All subjects received the approved dosing regimen for colon cleansing of 60 grams of sodium phosphate with a total liquid volume of 3.6 quarts. A 30-gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was given beginning at 6 PM in the evening. The 30-gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was repeated the following morning beginning at 6 AM.

Twenty-three healthy subjects (mean age 57 years old; 57% male and 43% female; and 65% Hispanic, 30% Caucasian, and 4% African-American) participated in this pharmacokinetic study. The serum phosphorus level rose from a mean (± standard deviation) baseline of 4.0 (± 0.7) mg/dL to 7.7 (± 1.6 mg/dL), at a median of 3 hours after the administration of the first 30-gram dose of sodium phosphate tablets (see Figure 1 ). The serum phosphorus level rose to a mean of 8.4 (± 1.9) mg/dL, at a median of 4 hours after the administration of the second 30-gram dose of sodium phosphate tablets.

The serum phosphorus level remained above baseline for a median of 24 hours after the administration of the initial dose of sodium phosphate tablets (range 16 to 48 hours). Figure 1. Mean (±Standard Deviation) Serum Phosphorus Concentrations The upper (4.5 mg/dL) and lower (2.6 mg/dL) reference limits for serum phosphate are represented by solid bars.

Specific Populations Male and Female Patients : No difference in serum phosphate AUC values were observed in the single pharmacokinetic study conducted with sodium phosphate tablets in 13 male and 10 female healthy subjects. Elderly Patients : In a single pharmacokinetic study of sodium phosphate tablets, which included 6 elderly subjects, plasma half-life increased two-fold in subjects > 70 years of age compared to subjects < 50 years of age (3 subjects and 5 subjects, respectively) [see Use in Specific Populations (8.5) ] .

Patients with Renal Impairment : The effect of renal impairment on the pharmacokinetics of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets has not been studied. The inorganic form of phosphate in the circulating plasma is excreted almost entirely by the kidneys [see Warnings and Precautions (5.1) , Use in Specific Populations (8.6) ]. graph

🧬 Mechanism of Action 37 words ▾

12.1Mechanism of Action The primary mode of action is the osmotic effect of sodium, which induces a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

📦 How Supplied / Storage and Handling 151 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white uncoated tablet, modified oval shaped, biconvex, bisect on one side and plain on the other. Debossed "N" on the left side of the bisect and "03" on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet contains 1.102 grams of monobasic sodium phosphate, USP and 0.398 grams of dibasic sodium phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet.

Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is packaged in a multi-dose, child-resistant bottle containing 100 tablets: NDC 43386-030-01. Each bottle contains two silica desiccant packets, which should not be ingested.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard any unused portion.

📋 Description 183 words ▾

11 DESCRIPTION Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) is an osmotic laxative used to clean the colon prior to colonoscopy. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white uncoated tablet, modified oval shaped, biconvex, bisect on one side and plain on the other.

Debossed "N" on the left side of the bisect and "03" on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet contains 1.102 grams of Monobasic Sodium Phosphate, USP and 0.398 grams of Dibasic Sodium Phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF.

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below: Monobasic sodium phosphate, USP Dibasic sodium phosphate, USP structure 1 structure 2

💬 Patient Medication Information ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Instruct patients: On the importance of taking the recommended fluid regimen. Advise them to hydrate adequately with clear liquids before, during, and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ] .

Examples of clear liquids can be found in the Medication Guide. Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are required for a complete preparation for colonoscopy. Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.

Not to take other laxatives or enemas made with sodium phosphate while they are taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Drug Interactions (7.3) ] . Not to take oral medications within one hour before or after starting each dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Drug Interactions (7.2) ] . To contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions (5.1,5.2,5.3) ].

To seek immediate medical care should signs and symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.7) ] . Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals Inc.

Baltimore, MD 21202 SAP Code: 265501 Iss. 05/2020 Medication Guide Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets s Read this Medication Guide before you start taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets? Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets can cause serious side effects, including: Serious kidney problems. Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, to clean the colon before colonoscopy.

These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Conditions that can make you more at risk for having serious kidney problems with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets include if you: lose too much body fluid (dehydration) have slow moving bowels have a blockage in your intestine (bowel obstruction) have any disease that causes bowel inflammation (colitis) have kidney disease or kidney problems have heart failure take water pills, high blood pressure medicine, or nonsteroidal anti-inflammatory drugs (NSAIDs) Increased age may increase your risk for having serious kidney problems with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

Severe fluid loss (dehydration) and severe changes in body salts in the blood (electrolytes). People who take medicines to clean their colon before a colonoscopy, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, can have severe loss of body fluid, with severe changes in body salts in the blood. These changes can be serious and can cause: abnormal heart rhythms kidney problems seizures.

This can happen even if you have never had a seizure. Tell your doctor if you have any of these symptoms of loss of too much body fluid (dehydration) while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets: vomiting… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pharmacokinetic studies with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets have not been conducted. However, the following pharmacokinetic study was conducted with another oral tablet formulation of sodium phosphate which contain the same active ingredients as Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets at a dose that is 25% greater than the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dose. Absorption An open-label pharmacokinetic study of oral sodium phosphate in healthy subjects was performed to determine the concentration-time profile of serum inorganic phosphorus levels after oral sodium phosphate administration.

All subjects received the approved dosing regimen for colon cleansing of 60 grams of sodium phosphate with a total liquid volume of 3.6 quarts. A 30-gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was given beginning at 6 PM in the evening. The 30-gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was repeated the following morning beginning at 6 AM.

Twenty-three healthy subjects (mean age 57 years old; 57% male and 43% female; and 65% Hispanic, 30% Caucasian, and 4% African-American) participated in this pharmacokinetic study. The serum phosphorus level rose from a mean (± standard deviation) baseline of 4.0 (± 0.7) mg/dL to 7.7 (± 1.6 mg/dL), at a median of 3 hours after the administration of the first 30-gram dose of sodium phosphate tablets (see Figure 1 ). The serum phosphorus level rose to a mean of 8.4 (± 1.9) mg/dL, at a median of 4 hours after the administration of the second 30-gram dose of sodium phosphate tablets.

The serum phosphorus level remained above baseline for a median of 24 hours after the administration of the initial dose of sodium phosphate tablets (range 16 to 48 hours). Figure 1. Mean (±Standard Deviation) Serum Phosphorus Concentrations The upper (4.5 mg/dL) and lower (2.6 mg/dL) reference limits for serum phosphate are represented by solid bars.

Specific Populations Male and Female Patients : No difference in serum phosphate AUC values were observed in the single pharmacokinetic study conducted with sodium phosphate tablets in 13 male and 10 female healthy subjects. Elderly Patients : In a single pharmacokinetic study of sodium phosphate tablets, which included 6 elderly subjects, plasma half-life increased two-fold in subjects > 70 years of age compared to subjects < 50 years of age (3 subjects and 5 subjects, respectively) [see Use in Specific Populations (8.5) ] .

Patients with Renal Impairment : The effect of renal impairment on the pharmacokinetics of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets has not been studied. The inorganic form of phosphate in the circulating plasma is excreted almost entirely by the kidneys [see Warnings and Precautions (5.1) , Use in Specific Populations (8.6) ].

🧬 Pharmacodynamics 26 words ▾

12.2Pharmacodynamics Administration of the recommended Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dosage regimen has a purgative effect for approximately 1 to 3 hours.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The colon cleansing efficacy and safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in a randomized, investigator-blinded, actively controlled, multicenter, U.S. trial in patients scheduled to have an elective colonoscopy (Study 1). In Study 1, patients were randomized into one of the following three sodium phosphate treatment groups: An oral tablet formulation of sodium phosphate containing 60 grams of sodium phosphate given in split doses (30 grams in the evening before the colonoscopy and 30 grams on the next day) with at least 3.6 quarts of clear liquids; Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets containing 60 grams of sodium phosphate given in split doses (30 grams in the evening before the colonoscopy and 30 grams on the next day) with 2.5 quarts of clear liquids; and Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets containing 48 grams of sodium phosphate (30 grams in the evening before the colonoscopy and 18 grams on the next day) with 2 quarts of clear liquids.

Patients were instructed to eat a light breakfast before noon on the day prior to the colonoscopy and then were told to drink only clear liquids after noon on the day prior to the colonoscopy. The primary efficacy endpoint was the overall colon cleansing response rate in the 4-point Colonic Contents Scale. Response was defined as a rating of "excellent" or "good" on the 4-point scale as determined by the blinded colonoscopist.

This trial was designed to assess the non-inferiority of the two Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets groups compared to the active control group. The efficacy analysis included 704 adult patients who had an elective colonoscopy. Patients ranged in age from 21 to 89 years old (mean age 56 years old) with 55% female and 45% male patients.

Race was distributed as follows: 87% Caucasian, 10% African American, and 3% other race. The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram and 48-gram treatment groups demonstrated non-inferiority compared to the active control. See Table 2 for the results.

1Colon cleansing efficacy was based on response rate to treatment. A patient was considered to be a responder if overall colon cleansing was rated as "excellent" or "good" on a 4-point scale based on the amount of retained "colonic contents". Excellent was defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization.

Good was defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. Fair was defined as >90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed. Inadequate was defined as <90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed.

2On the day of the colonoscopy, study medication was taken 3 to 5 hours before the start of the colonoscopy. Table 2: Phase 3 Study – Overall Colon Content Cleansing Response Rates 1 Treatment Arm (grams of sodium phosphate) No. of tablets taken at 6 PM on the day prior to colonoscopy No. of tablets taken the next day 2 Excellent Good Fair Inadequate Overall Response Rate (Excellent or Good) Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 32 tabs (48 g) n=236 20 12 76% 19% 3% 2% 95% Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 40 tabs (60 g) n=233 20 20 73% 24% 2% 1% 97% Sodium Phosphate Tablets 40 tabs (60 g) n=235 20 20 51% 43% 6% 0% 94% The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage regimen had a similar overall response rate as the 48-gram dosage regimen and was associated with an increased risk of adverse reactions [see Adverse Reactions (6.1) ] .

Therefore, the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage is not a recommended regimen [see Dosage and Administration (2.2) ].

📄 Recent Major Changes 10 words ▾

RECENT MAJOR CHANGES Warnings and Precautions ( 5.7 ) 11/2018

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PDP

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lupin Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43386-0028-60 · Lupin 43386-0038-60 · Lupin →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.