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Nicotine Polacrilex 4 mg Lozenge, 299,988-count

by Fertin Pharma A/S · 36 BOX in 1 CONTAINER (63443-3679-2) / 1 BAG in 1 BOX / 8333 LOZENGE in 1 BAG
NDC 63443-3679-02
🏷️ FDA NDC (as labeled) 63443-3679-2 billing pads the package segment with a zero
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) 63443-3679-2
Product NDC 63443-3679
11-digit billing NDC 63443367902
SPL Set ID 462b069b-6898-885c-e063-6294a90ab7ce
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-01
Dosage form LOZENGE
Substance NICOTINE
Why two NDCs? The FDA registers this code as 63443-3679-2 — 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 → 63443-3679-02. 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

LabelerFertin Pharma A/S
Labeler code63443
First marketedSep 2020
Product typeDrug For Further Processing
Portfolio25 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

📗 Our plain-language guide HelloPharmacist
  • It's a fair question. Nicotine is what makes cigarettes addictive, and it does raise your heart rate and blood pressure. But it's the thousands of other chemicals in cigarette smok...
  • Is nicotine replacement actually safe — isn't nicotine the thing that's bad for you?
  • It comes down to one simple question: when do you smoke your first cigarette of the day? If it's within 30 minutes of waking up, you're a heavier, more dependent smoker and you'll...
  • It depends on the form you're using. With the gum or lozenge, hiccups, heartburn, and a tingling in the mouth are pretty common — these usually mean you're using it a bit too fast....
📖 Read our full Nicotine guide →

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.

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
foster and thrive nicotine 4 mg 70677-1175-01 Strategic 72 lozenges $0.336 — Availability likely —
foster and thrive nicotine 4 mg 70677-1177-01 Strategic 72 lozenges $0.336 — Availability likely —
Nicotine Polacrilex 4 mg 45802-0873-05 Padagis 72 lozenges $0.336 — Availability likely —
Maxi Nicotine 4 mg 70000-0561-01 Cardinal 24 lozenges $0.336 — Availability likely —
good sense nicotine 4 mg 00113-0873-05 L. 72 lozenges $0.336 — Availability likely —
Maxi Nicotine 4 mg 00536-1338-09 Rugby 24 lozenges $0.336 — Availability likely —
Nicotine 4 mg 46122-0732-08 AmerisourceBergen 24 lozenges $0.336 — Availability likely —
Nicotine Mini 4 mg 70000-0559-01 Cardinal 27 lozenges $0.391 — Availability likely —
Mini Nicotine 4 mg 46122-0716-15 AmerisourceBergen 27 lozenges $0.391 — Availability likely —
Mini Nicotine 4 mg 00536-1241-81 Rugby 27 lozenges $0.391 — Availability likely —
Nicotine Polacrilex 4 mg 45802-0957-02 Padagis 81 lozenges $0.391 — Availability likely —
Good Sense Nicotine 4 mg 00113-0957-02 L. 81 lozenges $0.391 — Availability likely —
foster and thrive nicotine 4 mg 70677-1173-01 Strategic 81 lozenges $0.391 — Availability likely —
foster and thrive nicotine 4 mg 70677-1179-01 Strategic 81 lozenges $0.391 — Availability likely —
good sense nicotine 4 mg 00113-1190-10 L. 108 lozenges — — FDA listed —
Nicotine 4 mg 00363-9620-24 Walgreens 24 lozenges — — FDA listed —
signature care nicotine 4 mg 21130-0185-02 Safeway 81 lozenges — — FDA listed —
signature care nicotine 4 mg 21130-0211-05 Safeway 72 lozenges — — Discontinued —
Nicotine 4 mg 30142-0873-05 Kroger 72 lozenges — — FDA listed —
Nicotine 4 mg 41250-0957-02 Meijer 81 lozenges — — FDA listed —
exchange select nicotine 4 mg 55301-0873-16 Army 144 lozenges — — FDA listed —
exchange select nicotine 4 mg 55301-0957-60 Army 20 lozenges — — FDA listed —
Rexall Nicotine 4 mg 55910-0957-60 Dolgencorp, 20 lozenges — — FDA listed —
Nicotine 4 mg 58602-0836-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 4 mg 58602-0904-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 4 mg 58602-0906-07 Aurohealth 24 lozenges — — FDA listed —
berkley and jensen nicotine 4 mg 68391-0957-01 BJWC 27 lozenges — — FDA listed —
Nicotine 4 mg 69842-0564-10 CVS 10 lozenges — — FDA listed —
Nicotine Mini 4 mg 69842-0964-08 CVS 27 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0873-03 Amazon.com 24 lozenges — — FDA listed —
Nicotine 4 mg 00363-0424-05 Walgreen 72 lozenges — — FDA listed —
Mini Nicotine 4 mg 11822-0957-01 Rite 10 lozenges — — Discontinued —
care one nicotine 4 mg 41520-0873-05 American 72 lozenges — — FDA listed —
CareOne Mini Nicotine Polacrilex 4 mg 41520-0957-02 American 81 lozenges — — FDA listed —
Equate Nicotine 4 mg 49035-0190-10 Wal-Mart 108 lozenges — — FDA listed —
Equate Nicotine 4 mg 49035-0702-10 Wal-Mart 108 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 50090-1154-00 A-S 72 lozenges — — FDA listed —
Mini Nicotine 4 mg 55910-0662-20 Dolgencorp, 20 lozenges — — FDA listed —
kirkland signature quit 4 4 mg 63981-0873-37 Costco 270 lozenges — — FDA listed —
Nicotine 4 mg 69842-0595-27 CVS 80 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0509-58 Amazon.com 40 lozenges — — FDA listed —
topcare nicotine 4 mg 76162-0700-27 Topco 80 lozenges — — FDA listed —
equate nicotine 4 mg 79903-0182-20 WALMART 20 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0957-01 Amazon.com 27 lozenges — — FDA listed —
nicotine 4 mg 79481-1100-00 Meijer, 20 lozenges — — FDA listed —
Mini Nicotine 4 mg 79903-0128-08 WALMART 27 lozenges — — FDA listed —
up and up cherry nicotine 4 mg 82442-0190-03 Target 24 lozenges — — FDA listed —
up and up citrus mini nicotine 4 mg 82442-0399-07 Target 81 lozenges — — FDA listed —
up and up nicotine mini mint 4 mg 82442-0957-02 Target 108 lozenges — — FDA listed —
nicotine polacrilex 4 mg 50941-0957-00 L 336160 lozenges — — FDA listed —
Nicotine 4 mg 11822-0873-00 Rite 108 lozenges — — FDA listed —
Nicotine 4 mg 11822-0905-04 Rite 24 lozenges — — FDA listed —
Nicotine Mini 4 mg 30142-0209-02 Kroger 81 lozenges — — FDA listed —
Good Sense Nicotine 4 mg 00113-5023-27 L. 80 lozenges — — FDA listed —
Topcare Nicotine 4 mg 36800-0873-05 Topco 72 lozenges — — FDA listed —
Nicorette 4 mg 00135-0511-01 Haleon 72 lozenges — — FDA listed —
Habitrol Lozenge Original Flavor 4 mg 43598-0983-13 Dr. 135 lozenges — — FDA listed —
Habitrol Lozenge Cherry 4 mg 43598-0985-13 Dr. 135 lozenges — — FDA listed —
Mini Nicotine 4 mg 49035-0436-08 EQUATE 27 lozenges — — FDA listed —
Nicotine 4 mg 51316-0190-10 CVS 108 lozenges — — FDA listed —
Nicotine Mini 4 mg 57237-0321-42 Rising 24 lozenges — — FDA listed —
Nicotine 4 mg 59640-0151-27 H 80 lozenges — — FDA listed —
Mini Nicotine 4 mg 68016-0087-81 Chain 27 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 68071-3957-07 NuCare 216 lozenges — — FDA listed —
nicotine mini 4 mg 00363-1130-07 Walgreen 81 lozenges — — FDA listed —
Nicotine Mini 4 mg 00363-5770-20 Walgreens 20 lozenges — — FDA listed —
nicotine 4 mg 00363-7044-02 Walgreen 80 lozenges — — FDA listed —
Nicotine 4 mg 00363-9580-08 Walgreens 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 72888-0187-53 Advagen 27 lozenges — — FDA listed —
up and up cherry ice nicotine 4 mg 82442-0000-07 Target 81 lozenges — — FDA listed —
quitine mini nicotine 4 mg 84720-0009-07 QUITINE 216 lozenges — — FDA listed —
Nicotine 4 mg 11822-1649-00 Rite 80 lozenges — — FDA listed —
Nicotine 4 mg 21130-0636-05 Safeway 72 lozenges — — FDA listed —
good sense nicotine 4 mg 00113-7999-60 L. 20 lozenges — — FDA listed —
Topcare Nicotine 4 mg 36800-0957-02 Topco 81 lozenges — — FDA listed —
Nicorette 4 mg 00135-0636-01 Haleon 216 lozenges — — FDA listed —
Nicorette Cherry Peppermint 4 mg 00135-8071-20 Haleon 20 lozenges — — FDA listed —
Nicotine Mini 4 mg 00363-0979-81 Walgreens 27 lozenges — — FDA listed —
Members Mark Nicotine 4 mg 68196-0873-13 Sam's 189 lozenges — — Discontinued —
Nicotine Sugar Free 4 mg 69842-0858-24 CVS 24 lozenges — — FDA listed —
Mini Nicotine 4 mg 79481-0301-00 Meijer, 27 lozenges — — FDA listed —
equate nicotine 4 mg 79903-0104-08 WALMART 108 lozenges — — FDA listed —
Quitine Nicotine 4 mg 84720-0190-11 QUITINE 168 lozenges — — FDA listed —
Mini Nicotine 4 mg 17856-1241-01 ATLANTIC 50 lozenges — — FDA listed —
nicotine 4 mg 41250-0873-03 Meijer 24 lozenges — — FDA listed —
Nicotine Mini 4 mg 63548-0264-00 PLD 27 lozenges — — FDA listed —
Nicotine 4 mg 00363-0873-05 Walgreen 72 lozenges — — FDA listed —
members mark nicotine 4 mg 68196-0084-08 Sam's 216 lozenges — — FDA listed —
Mini Nicotine 4 mg 00363-2640-35 Walgreens 27 lozenges — — FDA listed —
Mini Nicotine 4 mg 79481-0957-02 Meijer, 81 lozenges — — FDA listed —
Blip 4 mg 82966-0303-00 Blip 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 83253-0979-27 HC 27 lozenges — — FDA listed —
Nicotine 4 mg 30142-0190-05 Kroger 72 lozenges — — FDA listed —
Nicorette 4 mg 00135-0626-01 Haleon 20 lozenges — — FDA listed —
nicotine 4 mg 59779-0873-04 CVS 48 lozenges — — FDA listed —
members mark mini nicotine 4 mg 68196-0957-07 Sam's 216 lozenges — — FDA listed —
nicotine mini 4 mg 00363-6011-07 Walgreen 81 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 72162-2288-02 Bryant 81 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 43598-0487-10 Dr. 108 lozenges — — Discontinued —
Nicotine Polacrilex 4 mgthis 63443-3679-02 Fertin 299988 lozenges — — FDA listed —
nicotine 4 mg 11822-0424-00 Rite 72 lozenges — — FDA listed —
Topcare Nicotine 4 mg 36800-0539-05 Topco 72 lozenges — — FDA listed —
Nicorette Peppermint 4 mg 00135-8060-20 Haleon 20 lozenges — — FDA listed —
nicotine 4 mg 37808-0563-10 H 108 lozenges — — FDA listed —
nicotine 4 mg 41250-0190-05 Meijer 72 lozenges — — FDA listed —
equate nicotine 4 mg 49035-0791-10 Wal-Mart 108 lozenges — — FDA listed —
stop smoking aid 4 mg 56062-0873-04 Publix 48 lozenges — — FDA listed —
berkley and jensen nicotine polacrilex 4 mg 68391-0873-13 BJWC 189 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0642-07 Amazon.com 81 lozenges — — FDA listed —
up and up mint nicotine 4 mg 82442-0873-03 Target 24 lozenges — — FDA listed —
Blip 4 mg 82966-0957-01 Blip 27 lozenges — — FDA listed —
nicotine 4 mg 30142-0797-07 Kroger 81 lozenges — — FDA listed —
Nicorette 4 mg 00135-1500-01 Haleon 20 lozenges — — FDA listed —
mini nicotine 4 mg 41250-0637-07 Meijer 81 lozenges — — FDA listed —
Amazon Basic Care Nicotine Polacrilex 4 mg 72288-0266-14 Amazon.com 144 lozenges — — FDA listed —
up and up nicotine 4 mg 82442-0741-27 Target 80 lozenges — — FDA listed —
Mini Nicotine 4 mg 83253-0264-27 HC 27 lozenges — — FDA listed —
nicotine 4 mg 11822-0009-01 Rite 72 lozenges — — FDA listed —
Nicotine 4 mg 42507-0690-10 HyVee 108 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 43598-0485-10 Dr. 108 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 43598-0489-10 Dr. 108 lozenges — — FDA listed —
Mini Nicotine 4 mg 59726-0264-27 P 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 59726-0652-04 P 27 lozenges — — FDA listed —
Nicotine 4 mg 59779-0957-02 CVS 81 lozenges — — FDA listed —
Mini Nicotine 4 mg 69842-0934-08 CVS 27 lozenges — — FDA listed —
Basic Care Nicotine 4 mg 72288-0190-03 Amazon.com 24 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 63443-3677-02 Fertin 299988 lozenges — — FDA listed —
Nicotine 4 mg 41250-0424-05 Meijer 72 lozenges — — FDA listed —
good sense nicotine 4 mg 50090-7060-00 A-S 72 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 71335-2730-01 Bryant 81 lozenges — — FDA listed —
Maxi Nicotine 4 mg 11822-3317-00 Rite 27 lozenges — — FDA listed —
Good Sense Nicotine 4 mg 00113-7031-14 L. 135 lozenges — — FDA listed —
equate nicotine 4 mg 49035-0873-03 Wal-Mart 24 lozenges — — FDA listed —
Nicotine 4 mg 00363-4190-05 Walgreen 72 lozenges — — FDA listed —
quitine nicotine 4 mg 84720-0007-76 QUITINE 120 lozenges — — FDA listed —
nicotine polacrilex 4 mg 00135-1502-03 Haleon 3700000 lozenges — — FDA listed —
Maxi Nicotine 4 mg 00363-0960-08 Walgreens 27 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 72162-2267-02 Bryant 72 lozenges — — FDA listed —
Basic Care Nicotine 4 mg 72288-0077-09 Amazon.com 27 lozenges — — FDA listed —
Dg Health Nicotine 4 mg 55910-0669-60 Dolgencorp 20 lozenges — — FDA listed —
nicotine coated 4 mg 56062-0681-60 Publix 20 lozenges — — FDA listed —
nicotine 4 mg 56062-0509-03 Publix 24 lozenges — — FDA listed —
nicotine 4 mg 56062-0671-24 Publix 24 lozenges — — FDA listed —
nicotine 4 mg 56062-0957-02 Publix 81 lozenges — — FDA listed —
Nicotine Mini 4 mg 72288-0375-01 Amazon.com 27 lozenges — — FDA listed —
Nicotine 4 mg 51316-0787-60 CVS 20 lozenges — — FDA listed —
Quitine Nicotine 4 mg 84720-0400-76 QUITINE 120 lozenges — — FDA listed —
nicotine 4 mg 59779-0424-00 CVS 108 lozenges — — FDA listed —
nicotine 4 mg 72288-0651-14 Amazon.com 216 lozenges — — FDA listed —
Nicotine Mini 4 mg 72288-0739-14 Amazon.com 135 lozenges — — FDA listed —
Nicotine 4 mg 72288-0869-76 Amazon.com 120 lozenges — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63443-3679-02 You're viewing this 36 BOX in 1 CONTAINER (63443-3679-2) / 1 BAG in 1 BOX / 8333 LOZENGE in 1 BAG — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Fertin Pharma A/S supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 63443-3679-2, 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: 63443-3679-02, written without dashes as 63443367902. 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 63443-3679-02, the first segment (63443) is the labeler code FDA assigned to Fertin Pharma A/S; the middle segment (3679) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Fertin Pharma A/S. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fertin Pharma A/S 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.
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 FDA label FDA SPL

The complete FDA label for this product, 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 ↗
← 63443-3678-02 · Fertin 63443-5057-01 · Fertin →
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.