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Novolin 70/30 Human Insulin 100 [iU]/mL Injection, Suspension — NDC 50090-0403-00 package photo

Novolin 70/30 Human Insulin 100 [iU]/mL Injection, Suspension

by A-S Medication Solutions · 1 VIAL in 1 CARTON (50090-0403-0) / 10 mL in 1 VIAL
NDC 50090-0403-00
🏷️ FDA NDC (as labeled) 50090-0403-0 billing pads the package segment with a zero
OTC Brand On market Non-controlled
🗂️ 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 50090-0403-0
Product NDC 50090-0403
11-digit billing NDC 50090040300
NCPDP billing unit ML — per mL (volume)
RxCUI 213442, 311048
UNII 1Y17CTI5SR
Application # BLA019991
SPL Set ID e825d7e9-467c-4f50-a6d6-f2602449c1de
Established class (EPC) Insulin
Chemical class Insulin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1991-06-25
Route SUBCUTANEOUS
Dosage form INJECTION, SUSPENSION
Substance INSULIN HUMAN
GPI-14 27104090001810
GPI class NovoLIN 70/30
GCN Seq No 016311
GCN 50001
HICL code 006215
Ingredient (HICL) Insulin Nph Hum/Reg Insulin Hm
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4G
Therapeutic class — specific (HIC3) Insulins
AHFS code 68:20.08.00
AHFS class Insulins
FDB label name NOVOLIN 70-30 100 UNIT/ML VIAL
FDB brand name Novolin 70-30
Legend status O — Over-the-counter (OTC) drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 50090-0403-0 — a 5-4-1 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 package segment → 50090-0403-00. 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.

🏭 Manufacturer & labeler

LabelerA-S Medication Solutions
FDA applicationBLA019991 (BLA)
Labeler code50090
First marketedJun 1991
Product typeHuman Otc Drug
Portfolio2,781 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 NOVOLIN 70-30 100 UNIT/ML VIAL Ingredient Insulin Nph Hum/Reg Insulin Hm
📖 What it is MedlinePlus · NLM

Human insulin is used to control blood sugar in people who have type 1 diabetes (condition in which the body does not make insulin and therefore cannot control the amount of sugar in the blood) or in people who have type 2 diabetes (condition in which the blood sugar is too high because the body does not produce or use insulin normally) that cannot be controlled with oral medications alone. Human insulin is in a class of medications called hormones. Human insulin is used to take the place of insulin that is normally produced by the body. It works by helping move sugar from the blood into other...

Read the full MedlinePlus article ↗

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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII GGO4Y809LO
    Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
  • UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII 0DE9724IHC
    Protamine sulfate is a protein derived from fish sperm that acts as a binder and stabilizer in medications. It helps hold tablet ingredients together and can improve the stability of certain drug formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII J41CSQ7QDS
    A mineral element that strengthens tablet structure and acts as a processing aid. Zinc helps bind ingredients together and may improve the medicine's stability during manufacturing and storage.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 mLPer 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 · Q2 2026 $5.82 $58.21 / 10 ml
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
Humulin 70/30 100 [iU]/mL 00002-8715-01 Eli 1 vial $4.258 — Availability likely —
Novolin R 100 [iU]/mL 00169-3003-15 Novo 5 syringes $5.816 — Availability likely —
Novolin N 100 [iU]/mL 00169-3004-15 Novo 5 syringes $5.823 — Availability likely —
Novolin 70/30 100 [iU]/mL 00169-3007-15 Novo 5 syringes $5.826 — Availability likely —
Novolin 70/30 100 [iU]/mL 00169-1837-02 Novo 1 vial — — FDA listed —
Novolin 70/30 100 [iU]/mLthis 50090-0403-00 A-S 1 vial — — FDA listed —
Novolin R 100 [iU]/mL 00169-1833-02 Novo 1 vial — — FDA listed —
Novolin N 100 [iU]/mL 00169-1834-02 Novo 1 vial — — FDA listed —
Novolin N 100 [iU]/mL 50090-6565-00 A-S 5 syringes — — Discontinued —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
1991
First FDA approval
Jun 1991
📍
2026
Currently FDA-listed
35 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Novolin 70-30 — the program that covers self-administered drugs. 2 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 Novolin 70-30. 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
$4.86M
Claims incl. refills
31.9K
Beneficiaries
20.5K
Spend / beneficiary
$237.69
Spend / claim
$152.32
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 Novolin 70/30 (this brand).

Top reported reactions

Blood Glucose Increased899
Nausea355
Blood Glucose Decreased349
Dyspnoea285
Dizziness254
Fatigue229
Diarrhoea223

Age at onset

Neonate4
Infant1
Child1
Adult472
Elderly436

Reporter sex

5,929 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization2,061
Death611
Life-threatening202
Disabling180
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 452 0
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
50090-0403-00 You're viewing this 1 VIAL in 1 CARTON (50090-0403-0) / 10 mL in 1 VIAL 2014-11-28 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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 ✓ Available
Inactive ingredients (structured) ✓ 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 FDA registers it as 50090-0403-0, 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: 50090-0403-00, written without dashes as 50090040300. 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 50090-0403-00, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (0403) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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 💬 Information for Patients
🎯 Indications and Usage 81 words ▾

1 INDICATIONS AND USAGE NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. NOVOLIN 70/30 is a mixture of human insulin isophane, an intermediate-acting human insulin, and human insulin, a short-acting human insulin, indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions. ( 2.1 ) • Inject subcutaneously in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) • Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal.

( 2.2 ) • Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes prior to start of meal. ( 2.2 ) • NOVOLIN 70/30 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). ( 2.2)

2.1Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. • NOVOLIN 70/30 is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature. • To resuspend vial, roll the vial gently in your hands in a horizontal position 10 times until the suspension appears uniformly white and cloudy. Inject immediately. • To resuspend FlexPen, gently move the pen up and down 20 times so the glass ball moves from one end of the cartridge to the other until the suspension appears uniformly white and cloudy.

Inject immediately. • Inspect NOVOLIN 70/30 visually before use. Do not use NOVOLIN 70/30 if discoloration or particulate matter is seen. • Administer NOVOLIN 70/30 by subcutaneous injection in the abdominal wall, thigh, upper arm, or buttocks. • Rotate the injection site within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )] . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] . • Do not administer NOVOLIN 70/30 intravenously and do not use in an insulin infusion pump. • Do not mix NOVOLIN 70/30 with any other insulins or diluents.

2.2Dosage Information • Individualize and adjust the dosage of NOVOLIN 70/30 based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal. • Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes before a meal. • NOVOLIN 70/30 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )]. • Dosage adjustment may be needed when switching from another insulin to NOVOLIN 70/30 [see Warnings and Precautions ( 5.2 )].

2.3Dosage Adjustment due to Drug Interactions • Dosage adjustment may be needed when NOVOLIN 70/30 is co-administered with certain drugs [see Drug Interactions ( 7 )] .

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Injectable suspension: 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), white and cloudy suspension available as: • 10 mL multiple-dose vial • 3 mL single-patient-use NOVOLIN 70/30 FlexPen prefilled pen Injectable suspension: 100 units/mL (U-100) available as: • 10 mL multiple-dose vial ( 3 ) • 3 mL single-patient-use NOVOLIN 70/30 FlexPen prefilled pen ( 3 )

⛔ Contraindications 64 words ▾

4 CONTRAINDICATIONS NOVOLIN 70/30 is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients who have had hypersensitivity reactions to NOVOLIN 70/30 or any of its excipients [see Warnings and Precautions ( 5.5 )] . • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to NOVOLIN 70/30 or any of its excipients ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Never share a NOVOLIN 70/30 FlexPen or syringe between patients, even if the needle is changed. ( 5.1 ) • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) • Hypoglycemia: May be life-threatening.

Increase frequency of blood glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. ( 5.3 ) • Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.

( 5.4 ) • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue NOVOLIN 70/30, monitor, and treat if indicated. ( 5.5 ) • Hypokalemia: May be life-threatening.

Monitor potassium levels in patients at risk for hypokalemia and treat if indicated. ( 5.6 ) • Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ( 5.7 )

5.1Never Share a NOVOLIN 70/30 FlexPen or Syringe between Patients NOVOLIN 70/30 FlexPen must never be shared between patients, even if the needle is changed. Patients using NOVOLIN 70/30 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3 )] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions ( 6 )] .

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction of all insulins, including NOVOLIN 70/30. Severe hypoglycemia can cause seizures, may lead to unconsciousness may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient 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 patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic neuropathy, 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. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.

As with all insulins, the time course of glucose lowering effect of NOVOLIN 70/30 may vary in different individuals or at different times in the same individual and depends on many…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Medication Errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLIN 70/30.

Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Adverse reactions associated with insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Hypersensitivity reactions Severe, life-threatening, generalized allergy, including anaphylaxis. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in NOVOLIN 70/30. Hypokalemia NOVOLIN 70/30 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.

Injection site reactions NOVOLIN 70/30 can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in NOVOLIN 70/30.

Lipodystrophy Administration of insulin subcutaneously, including NOVOLIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.1 )] in some patients. Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

Medication Errors Medication errors in which other insulins have been accidentally substituted for NOVOLIN 70/30 have been identified during postapproval use. Peripheral edema Insulins, including NOVOLIN 70/30, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Weight gain Weight gain can occur with insulins, including NOVOLIN 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The incidence of antibody formation with NOVOLIN 70/30 is unknown. Adverse reactions observed with NOVOLIN 70/30 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with NOVOLIN 70/30 Drugs that May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN 70/30 is co-administered with these drugs.

Drugs that May Decrease the Blood Glucose Lowering Effect of NOVOLIN 70/30 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN 70/30 is co-administered with these drugs.

Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLIN 70/30 Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN 70/30 is co-administered 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 NOVOLIN 70/30 is co-administered with these drugs. • Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. ( 7 ) • Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. ( 5.3 , 7 )

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed.

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA 1c >7 and has been reported to be as high as 20-25% in women with a HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. Data Human Data While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

All available studies have methodological limitations including lack of blinding, unclear methods of randomization, and small sample size.

8.2Lactation Risk Summary Available data from published literature suggests that exogenous human insulin products, including NOVOLIN 70/30, are transferred into human milk. There are no adverse reactions reported in the breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including NOVOLIN 70/30, on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NOVOLIN 70/30, and any potential adverse effects on the breastfed infant from NOVOLIN 70/30, or from the underlying maternal condition.

8.4Pediatric Use NOVOLIN 70/30 is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of NOVOLIN 70/30 must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )].

8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of NOVOLIN 70/30 has not been studied. Elderly patients using insulin, including NOVOLIN 70/30, may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions ( 5.3 )].

8.6Renal Impairment The effect of renal impairment on the pharmacokinetics and pharmacodynamics of NOVOLIN 70/30 has not been studied. Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent NOVOLIN 70/30 dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3 )] .

8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of NOVOLIN 70/30 has not been studied. Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent NOVOLIN 70/30 dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3 )] .

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed.

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA 1c >7 and has been reported to be as high as 20-25% in women with a HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. Data Human Data While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

All available studies have methodological limitations including lack of blinding, unclear methods of randomization, and small sample size.

🧒 Pediatric Use 58 words ▾

8.4Pediatric Use NOVOLIN 70/30 is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of NOVOLIN 70/30 must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )].

🧓 Geriatric Use 44 words ▾

8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of NOVOLIN 70/30 has not been studied. Elderly patients using insulin, including NOVOLIN 70/30, may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions ( 5.3 )].

🆘 Overdosage 83 words ▾

10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes with coma, seizure, or neurologic impairment can be treated with intramuscular or subcutaneous glucagon or intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately [see Warnings and Precautions ( 5.3 , 5.6 )] .

🧬 Clinical Pharmacology 131 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary activity of insulin, including NOVOLIN 70/30, is the regulation of glucose metabolism. Insulins lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

12.2Pharmacodynamics The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. NOVOLIN 70/30 is an intermediate-acting insulin with up to 24 hours duration of action. When injected subcutaneously, the glucose-lowering effect of NOVOLIN 70/30 begins approximately 30 minutes post-dose.

12.3Pharmacokinetics The pharmacokinetics of NOVOLIN 70/30 have been established. The effects of gender, age, obesity, renal and hepatic impairment on the pharmacokinetics of NOVOLIN 70/30 have not been studied.

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action The primary activity of insulin, including NOVOLIN 70/30, is the regulation of glucose metabolism. Insulins lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

📦 How Supplied / Storage and Handling 19 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-0403 NDC: 50090-0403-0 10 mL in a VIAL / 1 in a CARTON

📋 Description 213 words ▾

11 DESCRIPTION Insulin human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C 257 H 383 N 65 O 77 S 6 and a molecular weight of 5808 Da. NOVOLIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% of insulin isophane human, an intermediate-acting insulin, and 30% of insulin human, a short-acting insulin.

NOVOLIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection. Figure 1: Structural formula of human insulin NOVOLIN 70/30 is a sterile, white and cloudy injectable suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of NOVOLIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (1.9 mg), glycerin (16 mg), metacresol (1.5 mg), phenol (0.65 mg), protamine sulfate (approximately 0.25 mg), zinc (20.5 mcg/mL for the vial or 30.1 mcg for the FlexPen), and Water for Injection.

Hydrochloric acid 2N and sodium hydroxide 2N may be added during manufacture to adjust the pH. The pH is 7.1-7.5. Structural formula of human insulin

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a NOVOLIN 70/30 FlexPen or Syringe between Patients Advise patients using NOVOLIN 70/30 vials or NOVOLIN 70/30 FlexPen not to share needles, syringes, or FlexPen with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.1 )] .

Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of NOVOLIN 70/30 therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

Instruct patients on the management of hypoglycemia [see Warnings and Precautions ( 5.3 )] . Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.2 )] . Hypoglycemia due to Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with NOVOLIN 70/30.

Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see Warnings and Precautions ( 5.5 )] . Novolin ® , FlexPen ® and Novo Nordisk ® are registered trademarks of Novo Nordisk A/S. ReliOn ® is a registered trademark of Walmart Inc. and is used under license by Novo Nordisk Inc.

Patent Information: http://novonordisk-us.com/products/product-patents.html © 2022 Novo Nordisk Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536 1-800-727-6500 U.S. License Number 1261 For information about NOVOLIN 70/30 contact: Novo Nordisk Inc.

800 Scudders Mill Road Plainsboro, New Jersey 08536 www.novonordisk-us.com 1-800-727-6500 (Se habla español)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50090-0384-00 · A-S 50090-0404-00 · A-S →
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.