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NATEGLINIDE 60 mg Tablet, Coated, 100-count

by Nivagen Pharmaceuticals, Inc. · 100 TABLET, COATED in 1 BOTTLE (75834-205-01)
NDC 75834-0205-01
🏷️ FDA NDC (as labeled) 75834-205-01 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 75834-205-01
Product NDC 75834-205
11-digit billing NDC 75834020501
NCPDP billing unit EA — each (per item)
RxCUI 311919, 314142
UNII 41X3PWK4O2
UPC 0375834205014, 0375834206011
Application # ANDA206432
SPL Set ID 21b211b5-cc92-490f-9903-42fff6a946cd
Established class (EPC) Glinide
Mechanism of action Potassium Channel Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2019-09-25
Route ORAL
Dosage form TABLET, COATED
Substance NATEGLINIDE
GPI-14 27280040000320
GPI class Nateglinide
GCN Seq No 047333
GCN 12277
HICL code 021859
Ingredient (HICL) Nateglinide
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4K
Therapeutic class — specific (HIC3) Antihyperglycemic, Insulin-Release Stimulant Type
AHFS code 68:20.16.00
AHFS class Meglitinides
FDB label name NATEGLINIDE 60 MG TABLET
FDB brand name Nateglinide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 75834-205-01 — 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 → 75834-0205-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Glinide class.

Pharmacologic class Glinide
Drug family (ATC) Other blood glucose lowering drugs, excl. insulins
How it works Potassium Channel Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNivagen Pharmaceuticals, Inc.
Application holderCADILA PHARMACEUTICALS LTD
FDA applicationANDA206432 (ANDA)
Labeler code75834
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio95 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.

🩺 Clinical

Label name NATEGLINIDE 60 MG TABLET Ingredient Nateglinide
📖 What it is MedlinePlus · NLM

Nateglinide is used alone or in combination with other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) in people whose diabetes cannot be controlled by diet and exercise alone. Nateglinide belongs to a class of drugs called meglitinides. Nateglinide helps your body regulate the amount of glucose (sugar) in your blood. It decreases the amount of glucose by stimulating the pancreas to release insulin. Over time, people who have diabetes and high blood sugar can develop serious or life-t...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Nateglinide helps your pancreas release insulin right after you eat, which keeps your blood sugar from spiking too high after meals. It's specifically for type 2 diabetes and is me...
  • What exactly does nateglinide do for my diabetes?
  • Take it 1 to 30 minutes before each meal — three times a day. Timing matters here because it's designed to match your body's insulin release with the food you're about to eat. If y...
  • When exactly should I take my nateglinide tablet?
📖 Read our full Nateglinide guide →
1
Nutrient depletion considerations

Nateglinide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.190 $19.02 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2917 $29.17 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2683 $26.83 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.348 $0.173
▼ Down 36% over the last 24 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nateglinide 60 mg 60687-0673-21 American 30 tablets $0.190 AB Availability likely
Nateglinide 60 mg 72241-0002-04 Modavar 90 tablets $0.190 AB Availability likely
Nateglinide 60 mgthis 75834-0205-01 Nivagen 100 tablets $0.190 AB Discontinued
Nateglinide 60 mg 16571-0758-01 Rising 100 tablets AB FDA listed
Nateglinide 60 mg 51407-0656-01 Golden 100 tablets AB FDA listed
Nateglinide 60 mg 55111-0328-01 Dr. 100 tablets AB FDA listed
Nateglinide 60 mg 64380-0167-01 Strides 100 tablets AB FDA listed
Nateglinide 60 mg 68382-0721-01 Zydus 100 tablets AB FDA listed
Nateglinide 60 mg 70771-1015-00 Zydus 1000 tablets AB FDA listed
Nateglinide 60 mg 71209-0030-04 Cadila 90 tablets AB 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 75834-0205-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
185
Units reimbursed last 4 qtrs
23.4K
Gross reimbursed last 4 qtrs
$6.8K
Avg / prescription
$36.97
Avg / unit
$0.2917
Latest quarter Q4 2025
17Rx
Medicaid pays / ea
$0.2917
gross reimbursed
vs
NADAC / ea
$0.1902
acquisition cost
=
Spread
+$0.1015
+53% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
90% FFS
Fee-for-service · 167 Rx Managed care · 18 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 14,052 units · 71.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,800 units · 14.3 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 7,595 units · 19.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
14.371.8
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 71.8 /100k
2 California 19.5 /100k
3 Illinois 14.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nateglinide — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nateglinide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.75M
Claims incl. refills
34.8K
Beneficiaries
24.3K
Spend / beneficiary
$72.03
Spend / claim
$50.36
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Nateglinide — the ingredient across all brands.

Top reported reactions

Blood Glucose Increased76
Diarrhoea65
Dyspnoea64
Fatigue58
Nausea57
Renal Failure51
Death49

Reporter sex

1,332 reports
Male · 47%
Female · 53%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 95 27
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
75834-0205-01 You're viewing this 100 TABLET, COATED in 1 BOTTLE (75834-205-01) 2019-09-25 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 75834-205-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 75834-0205-01, written without dashes as 75834020501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 75834-0205-01, the first segment (75834) is the labeler code FDA assigned to Nivagen Pharmaceuticals, Inc.; the middle segment (0205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Nivagen 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 91 words

1 INDICATIONS AND USAGE Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis ( 1 ) Limitations of Use: Nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

⏱️ Dosage and Administration 144 words

2 DOSAGE AND ADMINISTRATION The recommended dose of nateglinide tablets is 120 mg orally three times daily before meals. The recommended dose of nateglinide tablets is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated. Instruct patients to take nateglinide tablets 1 to 30 minutes before meals.

In patients who skip meals, instruct patients to skip the scheduled dose of nateglinide tablets to reduce the risk of hypoglycemia {see Warnings and Precautions (5.1) ]. Recommended dose is 120 mg three times daily. In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered.

( 2 ) Administer 1 to 30 minutes before meals. ( 2 ) If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. ( 2 , 5.1 )

💊 Dosage Forms and Strengths 52 words

3 DOSAGE FORMS AND STRENGTHS 60 mg tablets: Pink, round, beveled edge tablet with "C" debossed on one side and "123" on the other side 120 mg tablets: Yellow, ovaloid tablet with "C" debossed on one side and "125" on the other side Tablets: 60 mg and 120 mg ( 3 )

Contraindications 30 words

4 CONTRAINDICATIONS Nateglinide is contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients. History of hypersensitivity to nateglinide or its inactive ingredients ( 4 )

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Hypoglycemia: Nateglinide may cause hypoglycemia. Administer before meals to reduce the risk of hypoglycemia. Skip the scheduled dose of nateglinide if a meal is skipped to reduce the risk of hypoglycemia. ( 5.1 ) Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide. ( 5.2 )

5.1Hypoglycemia All glinides, including nateglinide can cause hypoglycemia [see Adverse Reactions (6.1) ]. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy (nerve disease), in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) {see Drug Interactions (7) ), or in patients who experience recurrent hypoglycemia. Factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content), changes in level of physical activity, changes to coadministered medication {see Drug Interactions (7) ], and concomitant use with other antidiabetic agents.

Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6 , 8.7) , Clinical Pharmacology (12.3) ]. Patients should take nateglinide before meals and be instructed to skip the dose of nateglinide if a meal is skipped [see Dosage and Administration (2) 1. Patients and caregivers must be educated to recognize and manage hypoglycemia.

Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

5.2Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide.

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The following serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5. 1) ]

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. In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with nateglinide. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer.

Table 1 shows the most common adverse reactions associated with nateglinide. Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in Nateglinide -Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials Placebo N=458 Nateglinide N=1,441 Preferred Term Upper Respiratory Infection 8.1

10.5Back Pain 3.7

4.0Flu Symptoms 2.6

3.6Dizziness 2.2

3.6Arthropathy 2.2

3.3Diarrhea 3.1

3.2Accidental Trauma 1.7

2.9Bronchitis 2.6

2.7Coughing 2.2

2.4Hypoglycemia Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dl) were reported in two patients treated with nateglinide tablets. Non-severe hypoglycemia occurred in 2.4 % of nateglinide tablets treated patients and 0.4 % of placebo treated patients [see Warnings and Precautions (5.1) ]. Weight Gain Patients treated with nateglinide tablets had statistically significant mean increases in weight compared to placebo.

In clinical trials, the mean weight increases with nateglinide tablets 60 mg (3 times daily) and nateglinide tablets 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively. Laboratory Test Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with nateglinide tablets alone, nateglinide tablets in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dl, 0.45 m9/dl, 0.28 m9/dl, and 0.19 mg/dl.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of nateglinide tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions: Rash, itching, and urticaria Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

🔄 Drug Interactions 204 words

7 DRUG INTERACTIONS Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with nateglinide tablets and instructions for managing or preventing them. Table 2: Clinically Significant Drug Interactions with Nateglinide Drugs That May Increase the Blood-Glucose-Lowering Effect of Nateglinide and Susceptibility to Hypoglycemia Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g. methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g. amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol.

Intervention: Dose increases and increased frequency of glucose monitoring may be required when nateglinide tablets are coadministered with these drugs. Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Nateglinide and Increase Susceptibility to Hyperglycemia Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g. lanreotide, octreotide), and CYP inducers (e.g. rifampin, phenytoin and St John's Wort). Intervention: Dose increases and increased frequency of glucose monitoring may be required when nateglinide tablets are coadministered with these drugs.

Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: beta-blockers, clonidine, guanethidine, and reserpine Intervention: Increased frequency of glucose monitoring may be required when nateglinide tablets are coadministered with these drugs.

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy There are no adequate and well-controlled studies of nateglinide in pregnant women. It is unknown whether nateglinide can cause fetal harm when administered to a pregnant woman. Nateglinide tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the rabbit, embryonic development was adversely affected and the incidence of gall bladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 27 times the human therapeutic exposure of 120 mg three times daily, based on body surface area). Nateglinide was not teratogenic in rats at doses up to 1,000 mg/kg (approximately 27 times the human therapeutic exposure based on body surface area).

8.3Nursing Mothers It is not known whether nateglinide is excreted in human milk. Nateglinide is excreted in rat milk. Offspring of rats exposed to 1,000 mg/kg nateglinide (approximately 27 times the human therapeutic exposure of 120 mg three times daily, based on body surface area) had lower body weight.

Because the potential for hypoglycemia in nursing infants may exist, a decision should be made as to whether nateglinide should be discontinued in nursing mothers, or if mothers should discontinue nursing.

8.4Pediatric Use The safety and effectiveness of nateglinide have not been established in pediatric patients.

8.5Geriatric Use 436 patients 65 years and older, and 80 patients 75 years and older were exposed to nateglinide in clinical studies. No differences were observed in safety or efficacy of nateglinide tablets between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to nateglinide tablets therapy cannot be ruled out.

8.6Renal Impairment No dosage adjustment is recommended in patients with mild to severe renal impairment [see Clinical Pharmacology (12.3) ]. 8. 7 Hepatic Impairment No dose adjustment is recommended for patients with mild hepatic impairment. Use of nateglinide in patients with moderate-to-severe hepatic impairment has not been studied and therefore, should be used with caution in these patients [see Clinical Pharmacology (12.3) ].

🤰 Pregnancy 116 words

8.1Pregnancy There are no adequate and well-controlled studies of nateglinide in pregnant women. It is unknown whether nateglinide can cause fetal harm when administered to a pregnant woman. Nateglinide tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the rabbit, embryonic development was adversely affected and the incidence of gall bladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 27 times the human therapeutic exposure of 120 mg three times daily, based on body surface area). Nateglinide was not teratogenic in rats at doses up to 1,000 mg/kg (approximately 27 times the human therapeutic exposure based on body surface area).

🧒 Pediatric Use 16 words

8.4Pediatric Use The safety and effectiveness of nateglinide have not been established in pediatric patients.

🧓 Geriatric Use 60 words

8.5Geriatric Use 436 patients 65 years and older, and 80 patients 75 years and older were exposed to nateglinide in clinical studies. No differences were observed in safety or efficacy of nateglinide tablets between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to nateglinide tablets therapy cannot be ruled out.

🆘 Overdosage 86 words

10 OVERDOSAGE There have been no instances of overdose with nateglinide in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect with the development of hypoglycemic symptoms. Hypoglycemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns.

Severe hypoglycemic reactions with coma, seizure, or other neurological symptoms should be treated with intravenous glucose. As nateglinide are highly protein bound, dialysis is not an efficient means of removing it from the blood.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nateglinide lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets. Nateglinide interacts with the ATP-sensitive potassium (K + ATP ) channel on pancreatic beta-cells.

The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle.

12.2Pharmacodynamics Nateglinide tablets stimulates pancreatic insulin secretion within 20 minutes of oral administration. When nateglinide tablets are dosed before meals, the peak rise in plasma insulin occurs approximately 1 hour after dosing and falls to baseline by 4 hours after dosing.

12.3Pharmacokinetics In patients with Type 2 diabetes, multiple dose administration of nateglinide over the dosage range of 60 mg to 240 mg shows linear pharmacokinetics for both AUC and C MAX . In patients with Type 2 diabetes, there is no apparent accumulation of nateglinide upon multiple dosing of up to 240 mg three times daily for 7 days. Absorption Absolute bioavailability of nateglinide is approximately 73%.

Plasma profiles are characterized by multiple plasma concentration peaks when nateglinide is administered under fasting conditions. This effect is diminished when nateglinide is taken prior to a meal. Following oral administration immediately prior to a meal, the mean peak plasma nateglinide concentrations (C MAX ) generally occur within 1 hour (T MAX ) after dosing.

T MAX is independent of dose. The pharmacokinetics of nateglinide are not affected by the composition of a meal (high protein, fat, or carbohydrate). However, peak plasma levels are significantly reduced when nateglinide tablets are administered 10 minutes prior to a liquid meal as compared to solid meal.

When given with or after meals, the extent of nateglinide absorption (AUC) remains unaffected. However, there is a delay in the rate of absorption characterized by a decrease in C MAX and a delay in time to peak plasma concentration (T MAX ). Nateglinide tablets did not have any effect on gastric emptying in healthy subjects as assessed by acetaminophen testing.

Distribution Following intravenous (IV) administration of nateglinide, the steady-state volume of distribution of nateglinide is estimated to be approximately 10 L in healthy subjects. Nateglinide is extensively bound (98%) to serum proteins, primarily serum albumin, and to a lesser extent a acid glycoprotein. The extent of serum protein binding is independent of drug concentration over the test range of 0.1 to 10 mcg/ml.

Elimination In healthy volunteers and patients with type 2 diabetes mellitus, nateglinide plasma concentrations declined with an average elimination half-life of approximately 1.5 hours. Metabolism In vitro drug metabolism studies indicate that nateglinide tablets are predominantly metabolized by the cytochrome P450 isozyme CYP2C9 (70%) and to a lesser extent CYP3A4 (30%). The major routes of metabolism are hydroxylation followed by glucuronide conjugation.

The major metabolites are less potent antidiabetic agents than nateglinide. The isoprene minor metabolite possesses potency similar to that of the parent compound nateglinide. Excretion Nateglinide and its metabolites are rapidly and completely eliminated following oral administration.

Eighty-three percent of the 14c_nateglinide was excreted in the urine with an additional 10% eliminated in the feces. Approximately 16% of the 14c_Nateglinide was excreted in the urine as parent compound. Specific Populations Renal Impairment No pharmacokinetic data are available in subjects with mild renal impairment (CrCI 60 to 89 mL/min).

Compared to healthy matched subjects, patients with type 2 diabetes mellitus and moderate and severe renal…

🧬 Mechanism of Action 85 words

12.1Mechanism of Action Nateglinide lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets. Nateglinide interacts with the ATP-sensitive potassium (K + ATP ) channel on pancreatic beta-cells.

The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle.

📦 How Supplied / Storage and Handling 106 words

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 60 mg Nateglinide tablets, USP 60 mg are supplied as pink, round, beveled edge tablet with "C" debossed on one side and "123" on the other side. NDC Number Size NDC 75834-205-01 bottle of 100 120 mg Nateglinide tablets, USP 120 mg are supplied as yellow, ovaloid tablet with "C" debossed on one side and "125" on the other side. NDC Number Size NDC 75834-206-01 bottle of 100 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Dispense in a tight container (USP).

📦 Storage and Handling 31 words

Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Dispense in a tight container (USP).

📋 Description 159 words

11 DESCRIPTION Nateglinide, USP is an oral blood glucose-lowering drug of the glinide class. Nateglinide, USP (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown: Nateglinide is a white or almost white powder with a molecular weight of 317.42.

It is freely soluble in methanol, methylene chloride and in alcohol, soluble in ether, sparingly soluble in acetonitrile and in octanol, practically insoluble in water. Nateglinide tablets contain 60 mg, or 120mg, of nateglinide for oral administration. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, mannitol, iron oxide (yellow and red), polyethylene glycol, povidone, pre-gelatinized starch, sodium lauryl sulphate, sodium starch glycolate, sodium stearyl fumarate, talc and titanium dioxide.

Film-coating material contains opadry pink and opadry yellow for the 60 mg and 120 mg. Opadry pink contains hypromellose, iron oxide red, macrogol and titanium dioxide. Opadry yellow contains hypromellose, iron oxides (yellow and red), macrogol, titanium dioxide, and talc.

Chemical Structure

💬 Information for Patients 125 words

17 PATIENT COUNSELING INFORMATION Administration Instruct patients to take nateglinide tablets 1 to 30 minutes before meals. Instruct patients that skip meals to skip their dose of nateglinide tablets [see Dosage and Administration (2) ]. Hypoglycemia Inform patients that nateglinide tablets can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management of hypoglycemia.

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended [see Warnings and Precautions (5.1) ]. Drug Interactions Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with nateglinide tablets.

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