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Nicotine Transdermal System 21 mg/24h Patch — NDC 03215-1203-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicotine Transdermal System 21 mg/24h Patch — NDC 3215-1203-28 (Billing 03215-1203-28)

by Aveva Drug Delivery Systems Inc. · 28 POUCH in 1 CARTON / 24 h in 1 POUCH

This is a package of Nicotine Transdermal System 21 mg/24h Patch from Aveva Drug Delivery Systems Inc., marketed since Jun 2024 and currently FDA-listed.

NDC 03215-1203-28
🏷️ FDA NDC (as labeled) 3215-1203-28 billing pads the labeler segment with a zero
This package
Contains24 h in 1 pouch Pack sizes3 compare ↓
Product page 03215-1203-07 Also comes in: 7 pouches 3215-1203-07 14 pouches 3215-1203-14
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 3215-1203-28 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
3215 labeler · 1203 product · 28 package
Package marketed since
Jun 25, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3215120328 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 3215-1203-28
Product NDC 3215-1203
11-digit billing NDC 03215120328
RxCUI 198029, 198030, 198031
UNII 6M3C89ZY6R
Application # ANDA074612
SPL Set ID 7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-25
Route TRANSDERMAL
Dosage form PATCH
Substance NICOTINE
Quick answers
  • RxCUI (RxNorm): 198029
Why two NDCs? The FDA registers this code as 3215-1203-28 — 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 → 03215-1203-28. 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 Cholinergic Nicotinic Agonist class.

Pharmacologic class Cholinergic Nicotinic Agonist
Drug family (ATC) Drugs used in nicotine dependence
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • That's a really common concern, and it's worth addressing. Nicotine replacement products do deliver nicotine, but in a much more controlled way — without the tar, carbon monoxide,...
  • What exactly does nicotine replacement do — isn't it just replacing one nicotine habit with another?
  • Yes, it actually does matter. If you typically smoke your first cigarette within 30 minutes of waking up, your nicotine dependence is likely stronger, so you'd use the higher-stren...
  • How do I know which strength to use — and does it matter when I have my first cigarette in the morning?
📖 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.

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.
Try another pack size: 7 pouches 14 pouches
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
03215-1203-07 3215-1203-07 Main listing 7 POUCH in 1 CARTON / 24 h in 1 POUCH 2024-06-25 — Active
03215-1203-14 3215-1203-14 14 POUCH in 1 CARTON / 24 h in 1 POUCH 2024-06-25 — Active
03215-1203-28 You're viewing this 28 POUCH in 1 CARTON / 24 h in 1 POUCH 2024-06-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 28 pouch in 1 carton / 24 h in 1 pouch.
What NDC number is used to bill for this package of Nicotine Transdermal System 21 mg/24h Patch?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicotine 21 mg/24h 70677-0032-01 Strategic 14 pouches $1.533 — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 00536-1108-88 Rugby 14 patches $1.873 — Availability likely —
Nicotine 21 mg/24h 00536-5896-53 Rugby 7 pouches $1.873 — Availability likely —
Nicotine transdermal system step 1 21 mg/24h 43598-0448-28 Dr. 28 patches $1.873 — Discontinued —
Nicotine Transdermal System 21 mg/24h 46122-0353-74 AmerisourceBergen 14 pouches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 46122-0568-03 AmerisourceBergen 28 pouches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 50742-0670-07 Ingenus 7 pouches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 68001-0434-88 BluePoint 7 pouches $1.873 — Availability likely —
Nicotine Transdermal System Patch Step 1 21 mg/24h 68001-0699-88 BluePoint 7 patches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 70000-0512-01 Cardinal 7 pouches $1.873 — Availability likely —
Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 CARDINAL 7 patches $1.873 — Availability likely —
foster and thrive STEP 1 21 mg/24h 70677-1182-01 Strategic 14 pouches $1.873 — Availability likely —
Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 Strategic 14 patches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 76282-0783-40 EXELAN 14 pouches $1.873 — Availability likely —
Nicoderm Cq 21 mg/24h 00135-0194-01 Haleon 7 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 00363-0455-70 Walgreens 7 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 00363-1245-01 Walgreens 14 pouches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 03215-0122-14 Aveva 14 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24hthis 03215-1203-28 Aveva 28 pouches — — FDA listed —
Nicotine transdermal system 21 mg/24h 11673-0194-01 Target 7 patches — — Discontinued —
Nicotine transdermal system step 1 21 mg/24h 11822-4975-00 Rite 7 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 36800-0038-14 Topco 14 pouches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 37808-0461-01 H-E-B 14 pouches — — FDA listed —
Nicotine transdermal system 21 mg/24h 49035-0194-01 Wal-Mart 7 patches — — FDA listed —
Nicotine 21 mg/24h 50090-1697-00 A-S 14 pouches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 50090-7936-00 A-S 14 patches — — FDA listed —
Medline 21 mg 53329-0192-89 Medline 14 patches — — FDA listed —
Habitrol Step 1 21 mg/24h 55741-0448-28 Dr. 28 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 55910-0313-02 DOLGENCORP, 2 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 59450-0003-74 The 14 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 59779-0448-02 CVS 2 pouches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 60429-0445-14 Golden 14 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 63868-0735-14 Chain 14 patches — — FDA listed —
Nicotine 21 mg/24h 79481-0052-01 Meijer, 14 pouches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 21mg 21 mg/g 83364-0017-01 YITONGBADA 30 patches — — FDA listed —
Sefudun Quit Smoking Nicotine Patches 21 mg 83804-0001-01 Shenzhen 30 patches — — FDA listed —
NWRB Nicotine Transdermal Patch 21 mg 84288-0007-01 Dongkou 30 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 84720-0122-14 Quitine 14 patches — — FDA listed —
QUIT SMOKING Proven Patches 21 mg/g 84867-0013-01 Jiashen 30 patches — — FDA listed —
Rstrvbr QUIT SMOKING 21 mg/1001 85248-0130-01 Jiangxi 30 patches — — FDA listed —
Serynth Nicotine Transdermal Stop Smoking Aid 21 mg/1001 85248-0164-01 Jiangxi 21 patches — — FDA listed —
Nicotine Patches 21 mg/21mg 85333-0003-02 Zhejiang 14 patches — — FDA listed —
Nicotine Patches 21 mg/1001 85795-0002-01 Shenzhen 30 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0004-01 Shenzhen 30 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0009-01 Shenzhen 30 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 1 Step 21 mg/1001 85835-0012-01 Shenzhen 30 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 1-3 Step 21 mg/1001 85835-0013-01 Shenzhen 30 patches — — FDA listed —
quit smoking patches 21 mg 87135-0001-01 Henan 30 patches — — FDA listed —
GUHIO Nicotine Patch 21 mg 87278-0001-01 Guangxi 42 patches — — FDA listed —
Nicotine Stop Smoking AID 21 mg 87278-0002-01 Guangxi 60 patches — — FDA listed —
Nicotine Stop Smoking AID 21 mg 87278-0009-01 Guangxi 60 patches — — FDA listed —
Hqlsey Quit Smoking Patches 21 mg/1001 87405-0001-01 Hansen 14 patches — — FDA listed —
Nicotine Patch 21 mg 87704-0004-01 Guangzhou 30 patches — — 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

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.

🧪 Avoiding an ingredient? See Nicotine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesacrylate adhesive, polyester, silicone adhesive

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerAveva Drug Delivery Systems Inc.
Application holderDIFGEN PHARMACEUTICALS LLC
FDA applicationANDA074612 (ANDA)
Labeler code03215
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio20 products on file

More NDCs from Aveva Drug Delivery Systems Inc. labeler code 03215

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

⏱️ Dosage and Administration ~1 min read ▾

Directions If you are under 18 years of age, ask a doctor before use before using this product, read the enclosed self-help guide for complete directions and other information begin using the patch on your quit day If you smoke more than 10 cigarettes per day , use the following schedule below: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 Step 1 Step 2 Step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks apply one new patch every 24 hours on skin that is dry, clean, and hairless remove backing from patch and immediately press onto skin.

Hold for 10 seconds. wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each day if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours it is important to complete treatment.

If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

⚠️ Warnings ~1 min read ▾

Warnings If you are pregnant or breast feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have heart disease, recent heart attack, or irregular heartbeat.

Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product if you have vivid dreams or other sleep disturbances, remove the patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness, and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

🧪 Active Ingredient 36 words ▾

Active ingredient (in each patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 7 mg delivered over 24 hours

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients acrylate adhesive, polyester, silicone adhesive

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Ask a Doctor Before Use If 59 words ▾

Ask a doctor before use if you have heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. stomach ulcer or diabetes history of seizures

📄 Ask a Doctor or Pharmacist Before Use If 32 words ▾

Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

📄 When Using This Product 18 words ▾

When using this product if you have vivid dreams or other sleep disturbances, remove the patch at bedtime

📄 Stop Use and Ask a Doctor If 63 words ▾

Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness, and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash)

🤰 If Pregnant or Breast-Feeding 57 words ▾

If you are pregnant or breast feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

📄 Keep Out of Reach of Children 53 words ▾

Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-333-6127

📄 Package Label / Principal Display Panel 203 words ▾

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON NDC 3215-1203-07 COMPARE TO HABITROL ® ​ ACTIVE INGREDIENT* CLEAR Nicotine Transdermal System Patch 21 mg delivered over 24 hours STOP SMOKING AID Includes: Behavior support program with self-help guide If you smoke more than 10 cigarettes per day: Start with step 1 If you smoke 10 or less cigarettes per day: Start with Step 2. STEP 1 21 mg - 14 PATCHES 21 mg CARTON

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON NDC 3215-1202-07 COMPARE TO HABITROL ® ACTIVE INGREDIENT* CLEAR Nicotine Transdermal System Patch 14 mg delivered over 24 hours STOP SMOKING AID Includes: Behavior support program with self-help guide If you smoke more than 10 cigarettes per day: Start with step 1 If you smoke 10 or less cigarettes per day: Start with step 2 STEP 2 14 mg - 14 PATCHES 14 mg CARTON

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON NDC 3215-1201-07 COMPARE TO HABITROL ® ACTIVE INGREDIENT* CLEAR Nicotine Transdermal System Patch 14 mg delivered over 24 hours STOP SMOKING AID Includes: Behavior support program with self-help guide For use after completing step 2 STEP 3 7 mg - 14 PATCHES 7 mg CARTON

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

About this NDC listing & data coverage

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aveva Drug Delivery Systems Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 7 pouches (03215-1203-07), 14 pouches (03215-1203-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aveva Drug Delivery Systems 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 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.
← 03215-1202-07 · Aveva 03215-1521-04 · Aveva →
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.