Home › NDC Lookup › Ingredients › Human Insulin › 00169-3004-15
💉image loading
(from DailyMed)

Novolin N Human Insulin 100 [iU]/mL Injection, Suspension — NDC 0169-3004-15 (Billing 00169-3004-15)

by Novo Nordisk Pharmaceutical Industries, LP · 5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC

This is a package of Novolin N Human Insulin 100 [iU]/mL Injection, Suspension from Novo Nordisk Pharmaceutical Industries, LP, marketed since Sep 2019 and currently FDA-listed; retail pharmacies pay about $5.82 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 00169-3004-15
🏷️ FDA NDC (as labeled) 0169-3004-15 billing pads the labeler segment with a zero
This package
Contains3 mL in 1 syringe, plastic Cost per mL$5.82 NADAC Per package$87.37 / 15 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $6.48/unit · Part D plans $5.81/unit — full pricing hub ↓
Main listing for product 0169-3004 · Also comes in: 5 syringes 0169-3004-25
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0169-3004-15 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0169 labeler · 3004 product · 15 package
Package marketed since
Sep 6, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0169300415 4
Medicaid fills, this package
14,252 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0169-3004-15
Product NDC 0169-3004
11-digit billing NDC 00169300415
NCPDP billing unit ML — per mL (volume)
Application # BLA019959
SPL Set ID 8c93638d-0c33-47f9-9846-332703a02151
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 2019-09-06
Route SUBCUTANEOUS
Dosage form INJECTION, SUSPENSION
Substance INSULIN HUMAN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 051292
GCN 18488
HICL code 000780
Ingredient (HICL) Insulin Nph Human Isophane
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 N 100 UNIT/ML FLEXPEN
FDB brand name Novolin N Flexpen
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 051292
  • GCN: 18488
  • HICL (First Databank): 000780
  • AHFS class code: 68:20.08.00
Why two NDCs? The FDA registers this code as 0169-3004-15 — a 4-4-2 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 labeler segment → 00169-3004-15. 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

Label name NOVOLIN N 100 UNIT/ML FLEXPEN Ingredient Insulin Nph Human Isophane
📖 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.

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 $5.825 $87.37 / 15 ml
Medicaid paysCMS SDUD · 12 mo $6.48 $97.24 / 15 ml
Medicare drug plans payPart D · Q2 2026 $5.81 $87.12 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Jun 2021 Dec 2025 Apr 2026 Sep 2026 $16.757 $5.820
▼ Down 65% over the last 14 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00169-3004-15 You're viewing this Main listing 5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC $5.82 / mL $87.37 2019-09-06 — Active
00169-3004-25 0169-3004-25 5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC — — 2019-09-06 — Active

In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic.
What NDC number is used to bill for this package of Novolin N Human Insulin 100 [iU]/mL Injection, Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Novolin R 100 [iU]/mL 00169-3003-15 Novo 5 syringes $5.815 — Availability likely +0%
Novolin N 100 [iU]/mLthis 00169-3004-15 Novo 5 syringes $5.824 — Availability likely —
Novolin 70/30 100 [iU]/mL 00169-3007-15 Novo 5 syringes $5.825 — Availability likely +0%
Humulin N 100 [iU]/mL 00002-8805-59 Eli 5 syringes $9.033 — Availability likely +55%
Novolin N 100 [iU]/mL 50090-6565-00 A-S 5 syringes — — Discontinued —
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 70/30 100 [iU]/mL 00169-1837-02 Novo 1 vial — — FDA listed —
Novolin 70/30 100 [iU]/mL 50090-0403-00 A-S 1 vial — — FDA listed —
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
Jul 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.

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

LabelerNovo Nordisk Pharmaceutical Industries, LP
FDA applicationBLA019959 (BLA)
Labeler code00169
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio39 products on file

More NDCs from Novo Nordisk Pharmaceutical Industries, LP labeler code 00169

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.

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

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 this package alone, 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 – Q1 2026 · 5 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
14.3K
Units reimbursed last 4 qtrs
224.3K
Gross reimbursed last 4 qtrs
$1.45M
Avg / prescription
$102.04
Avg / unit
$6.4827
Latest quarter Q1 2026
3.2KRx
Medicaid pays / mL
$6.4827
gross reimbursed
vs
NADAC / mL
$5.8245
acquisition cost
=
Spread
+$0.6582
+11% vs cost
What Medicaid paid per mL (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 ⓘ
43% FFS 57% MCO
Fee-for-service · 6,078 Rx Managed care · 8,174 Rx
State Medicaid map
Alaska: no data reported AK Maine: 576 units · 41.3 per 100k residents ME Washington: 168 units · 2.2 per 100k residents WA Idaho: 318 units · 16.2 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,550 units · 44.4 per 100k residents MN Wisconsin: no data reported WI Michigan: 11,052 units · 110 per 100k residents MI New York: 22,104 units · 113 per 100k residents NY Vermont: 189 units · 29.2 per 100k residents VT New Hampshire: no data reported NH Oregon: 5,061 units · 120 per 100k residents OR Nevada: 3,231 units · 101 per 100k residents NV Wyoming: no data reported WY South Dakota: 483 units · 52.6 per 100k residents SD Iowa: 4,707 units · 147 per 100k residents IA Illinois: 180 units · 1.4 per 100k residents IL Indiana: 9,903 units · 144 per 100k residents IN Ohio: 3,267 units · 27.7 per 100k residents OH Pennsylvania: 9,954 units · 76.8 per 100k residents PA New Jersey: 2,205 units · 23.7 per 100k residents NJ Massachusetts: 20,604 units · 294 per 100k residents MA California: 37,860 units · 97.2 per 100k residents CA Utah: 362 units · 10.6 per 100k residents UT Colorado: 9,405 units · 160 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,050 units · 23.2 per 100k residents KY West Virginia: 3,324 units · 188 per 100k residents WV Virginia: 1,083 units · 12.4 per 100k residents VA Maryland: 5,526 units · 89.4 per 100k residents MD Connecticut: 966 units · 26.7 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,053 units · 14.2 per 100k residents AZ New Mexico: 7,206 units · 341 per 100k residents NM Kansas: 1,716 units · 58.4 per 100k residents KS Arkansas: no data reported AR Tennessee: 5,328 units · 74.8 per 100k residents TN North Carolina: 2,667 units · 24.6 per 100k residents NC South Carolina: 744 units · 13.8 per 100k residents SC Delaware: 2,661 units · 258 per 100k residents DE Oklahoma: 3,510 units · 86.6 per 100k residents OK Louisiana: 336 units · 7.3 per 100k residents LA Mississippi: 177 units · 6.0 per 100k residents MS Alabama: 2,661 units · 52.1 per 100k residents AL Georgia: 5,139 units · 46.6 per 100k residents GA D.C.: no data reported DC Hawaii: 3,111 units · 217 per 100k residents HI Texas: 28,584 units · 93.7 per 100k residents TX Florida: 3,312 units · 14.6 per 100k residents FL
Units reimbursed · per 100k residents
1.4341
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 Mexico 341 /100k
2 Massachusetts 294 /100k
3 Delaware 258 /100k
4 Hawaii 217 /100k
5 West Virginia 188 /100k
6 Colorado 160 /100k
7 Iowa 147 /100k
8 Indiana 144 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
5 syringes this page00169-3004-15 14,252 Rx · $1,454,280
5 syringes00169-3004-25 1,660 Rx · $80,558
Drug total (last 4 qtrs): 15,912 Rx · 249,704 units · $1,534,837 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Novolin N — 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 N. 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
$2.47M
Claims incl. refills
19.2K
Beneficiaries
12.7K
Spend / beneficiary
$194.28
Spend / claim
$128.86
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.
← 00169-3003-15 · Novo 00169-3007-15 · Novo →
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.