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Levonorgestrel 1.5 mg Tablet, 1 tablet — NDC 40032-622-30 (Billing 40032-0622-30)

by Novel Laboratories, Inc. · 1 TABLET in 1 CARTON

This is a package of 1 tablet of Levonorgestrel 1.5 mg Tablet from Novel Laboratories, Inc., marketed since Feb 2013 and currently FDA-listed. It is this product's only package size.

NDC 40032-0622-30
🏷️ FDA NDC (as labeled) 40032-622-30 billing pads the product segment with a zero
Rx only 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 40032-622-30
Product NDC 40032-622
11-digit billing NDC 40032062230
RxCUI 483325
UNII 5W7SIA7YZW
UPC 0340032622307
Application # ANDA202508
SPL Set ID ac13a073-a33a-45f7-8483-eecc9190195f
Established class (EPC) Progestin; Progestin-containing Intrauterine System
Physiologic effect Inhibit Ovum Fertilization
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-02-15
Route ORAL
Dosage form TABLET
Substance LEVONORGESTREL
Quick answers
  • RxCUI (RxNorm): 483325
Why two NDCs? The FDA registers this code as 40032-622-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 40032-0622-30. 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 Progestin class.

Pharmacologic class Progestin, Progestin-containing Intrauterine System
Drug family (ATC) Progestogens and estrogens, sequential preparations, Progestogens, Emergency contraceptives
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
  • It comes in two main types. The intrauterine systems (Mirena, Liletta, Kyleena, Skyla) prevent pregnancy for years, and Mirena and Liletta also treat heavy menstrual bleeding. The...
  • Take it as soon as you can, within 72 hours (3 days) of unprotected sex. The sooner you take it, the better it works. If you vomit within 2 hours, call a healthcare professional to...
  • How do I take the emergency contraceptive tablet?
  • No. It's a backup method and isn't as effective as regular birth control. It also won't work if you're already pregnant, and it doesn't protect against HIV or other STDs.
📖 Read our full Levonorgestrel guide →
2
Nutrient depletion considerations

Levonorgestrel may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Levonorgestrel nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
40032-0622-30 You're viewing this Main listing 1 TABLET in 1 CARTON 2013-02-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Option 2 1.5 mg 00113-2003-12 L. 1 tablet $6.331 — Availability likely —
Levonorgestrel 1.5 mg 00536-1433-63 Rugby 1 tablet $6.331 — Availability likely —
New Day 1.5 mg 16714-0809-01 Northstar 1 tablet $6.331 — Availability likely —
EContra One-Step 1.5 mg 50102-0211-13 Afaxys 3 tablets $6.331 — Availability likely —
My Choice TM 1.5 mg 62756-0720-60 SUN 1 tablet $6.331 — Availability likely —
My Way 1.5 mg 68180-0852-11 Lupin 1 tablet $6.331 — Availability likely —
Levonorgestrel 1.5 mg 70700-0164-06 Xiromed 1 tablet $6.331 — Availability likely —
Her Style 1.5 mg 50742-0352-01 Ingenus 1 tablet $6.797 — FDA listed —
Opcicon One-Step 1.5 mg 62756-0718-60 Sun 1 tablet $6.797 — FDA listed —
Levonorgestrel 1.5 mgthis 40032-0622-30 Novel 1 tablet — — FDA listed —
My Way 1.5 mg 43386-0622-30 Lupin 1 tablet — — FDA listed —
Plan B One-Step 1.5 mg 50090-5978-00 A-S 1 tablet — — FDA listed —
My Choice 1.5 mg 51660-0096-11 OHM 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 51660-0723-11 Ohm 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 51660-0999-11 Ohm 1 tablet — — FDA listed —
Fem Choice morning after 1.5 mg 58602-0712-28 Aurohealth 1 tablet — — FDA listed —
Athentia Next 1.5 mg 58602-0721-57 Aurohealth 1 tablet — — FDA listed —
Econ Morning After 1.5 mg 58602-0841-48 Aurohealth 3 tablets — — FDA listed —
After Banger 1.5 mg 58602-0891-57 Aurohealth 1 tablet — — FDA listed —
Ithappenz Morning After 1.5 mg 58602-0892-57 Aurohealth 1 tablet — — FDA listed —
Levonorgestrel Tablet, 1.5 mg 59556-0282-01 Strides 1 tablet — — FDA listed —
Optionelle 1.5 mg 59556-0286-01 Strides 1 tablet — — FDA listed —
Emergency Contraceptive 1.5 mg 59726-0138-01 P 1 tablet — — Discontinued —
AfterPlan 1.5 mg 62756-0723-60 SUN 1 tablet — — FDA listed —
AfterPill 1.5 mg 64122-0605-01 Syzygy 1 tablet — — FDA listed —
My Way 1.5 mg 68071-4294-01 NuCare 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 69230-0333-32 Camber 1 tablet — — FDA listed —
Aftera 1.5 mg 69536-0103-88 Foundation 1 tablet — — FDA listed —
Next Choice One Dose 1.5 mg 69536-0133-88 Foundation 1 tablet — — FDA listed —
Plan B One-Step 1.5 mg 69536-0146-19 Foundation 1 tablet — — FDA listed —
Plan B One-Step 1.5 mg 69536-0162-88 Foundation 1 tablet — — FDA listed —
Take Action 1.5 mg 69536-0200-88 Foundation 1 tablet — — FDA listed —
Morning After 1.5 mg/1.5mg 69953-0515-01 Rapha 1 mg — — FDA listed —
Morning After 1.5 mg/1.5mg 69953-0516-01 Rapha 1 mg — — FDA listed —
Morning After 1.5 mg/1.5mg 69953-0517-01 Rapha 1 mg — — FDA listed —
PostDay One-Step 1.5 mg/1.5mg 69953-0617-42 Rapha 1 mg — — FDA listed —
PostDay One-Step 1.5 mg/1.5mg 69953-0618-43 Rapha 1 mg — — FDA listed —
PostDay One-Step 1.5 mg/1.5mg 69953-0628-60 Rapha 1 mg — — FDA listed —
LEADER Emergency Contraceptive Levonorgestrel 1.5 mg 70000-0600-01 Cardinal 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 70000-0675-01 LEADER/ 1 tablet — — FDA listed —
My Choice TM 1.5 mg 71205-0120-01 Proficient 1 tablet — — FDA listed —
My Way 1.5 mg 71205-0361-01 Proficient 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 71713-0098-11 Thirty 1 tablet — — FDA listed —
Amazon Basic Care Levonorgestrel 1.5 mg 72288-0324-28 Amazon.com 1 tablet — — FDA listed —
SheWise 1.5 mg 72657-0108-11 GLENMARK 1 tablet — — Discontinued —
Levonorgestrel 1.5 mg 72657-0123-11 GLENMARK 1 tablet — — FDA listed —
Morning After Pill 1.5 mg 73436-2859-01 Cadence 1 tablet — — FDA listed —
Morning After Pill 1.5 mg 73436-8292-01 Cadence 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 73581-0217-01 YYBA 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 79929-0016-01 Naari 1 tablet — — FDA listed —
Restart 1.5 mg 80584-0103-01 Winx 1 tablet — — FDA listed —
Julie Morning After Pill 1.5 mg 82791-0002-01 Julie 1 tablet — — FDA listed —
Julie Morning After Pill 1.5 mg 82791-0003-01 Julie 1 tablet — — FDA listed —
Julie 1.5 mg 82791-0335-01 Julie 1 tablet — — FDA listed —
Julie 1.5 mg 82791-0532-01 Julie 1 tablet — — FDA listed —
Julie 1.5 mg 82791-0538-01 Julie 1 tablet — — FDA listed —
PostDay One-Step 1.5 mg 85506-0100-10 Home 1 tablet — — FDA listed —
Option 2 1.5 mg 00113-8099-12 L. 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 73581-0017-01 YYBA 1 tablet — — FDA listed —
Julie Morning After Pill 1.5 mg 82791-0004-01 Julie 1 tablet — — FDA listed —
My After Plan 1.5 mg 51660-0098-11 OHM 1 tablet — — 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

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 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.

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

LabelerNovel Laboratories, Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA202508 (ANDA)
Labeler code40032
First marketedFeb 2013
Product typeHuman Prescription Drug
Portfolio22 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🧪 Active Ingredient 4 words ▾

Active Ingredient Levonorgestrel 1.5mg

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and talc

🎯 Purpose 58 words ▾

Purpose Emergency contraceptive Use for women to reduce the chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) Warnings Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

📄 Do Not Use 49 words ▾

Do not use if you are already pregnant (because it will not work) for regular birth control . Ask a doctor or pharmacist before use if you are Taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

📄 When Using This Product 20 words ▾

When using this product you may have menstrual changes nausea lower stomach (abdominal) pain tiredness headache dizziness breast pain vomiting

📄 Keep Out of Reach of Children 131 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away. Directions take as soon as possible within 72 hours (3 days) after unprotected sex.

The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose. Other information read the instructions, warnings and enclosed product leaflet before use this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation). do not use if carton is open or blister seal is broken or missing store at 20-25°C (68-77°F)

📄 Questions or Comments ~3 min read ▾

Questions? For more information or to speak to a healthcare professional, call 1-800-422-8689 or visit our website at www.mywaypill.com Levonorgestrel Tablet Emergency Contraceptive What You Need to Know What is Levonorgestrel Tablet? Levonorgestrel Tablet is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex.

It is a backup method of preventing pregnancy and should not be used as regular birth control. What Levonorgestrel Tablet is not. Levonorgestrel Tablet will not work if you are already pregnant and will not affect an existing pregnancy.

Levonorgestrel Tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs). When should I use Levonorgestrel Tablet? The sooner you take emergency contraception, the better it works.

You should use Levonorgestrel Tablet within 72 hours (3 days) after you have had unprotected sex . Levonorgestrel Tablet is a backup or emergency method of birth control you can use when: your regular birth control was used incorrectly or failed you did not use any birth control method When not to use Levonorgestrel Tablet. Levonorgestrel Tablet should not be used: as a regular birth control method, because it's not as effective as regular birth control. if you are already pregnant, because it will not work. if you are allergic to levonorgestrel or any other ingredients in Levonorgestrel Tablet.

When should I talk to a doctor or pharmacist? Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Levonorgestrel Tablet and increase your chance of becoming pregnant.

Your doctor may prescribe another form of emergency contraception that may not be affected by these medications. How does Levonorgestrel Tablet work? Levonorgestrel Tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades.

Levonorgestrel Tablet contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Levonorgestrel Tablet may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

How can I get the best results from Levonorgestrel Tablet? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablet, the better it works.

How effective is Levonorgestrel Tablet? If Levonorgestrel Tablet is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know Levonorgestrel Tablet worked? You will know Levonorgestrel Tablet has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant.

You should get a pregnancy test and follow up with your healthcare professional. Will I experience any side effects? some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant. if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention. when used as directed, Levonorgestrel Tablet is safe and effective.

Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness. if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose. What if I still have questions a… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 28 words ▾

PRINCIPAL DISPLAY PANEL Levonorgestrel Tablet, 1.5 mg NDC 40032-622-30 emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. Contains 1 Tablet 1.5mg Levonorgestrel_carton

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

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

Medicare Part D (outpatient prescription) spending for Mirena (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Mirena. CMS lists 4 products for this generic; we show the highest-spend one. 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
$198.1K
Claims incl. refills
161
Beneficiaries
160
Spend / beneficiary
$1,238.34
Spend / claim
$1,230.65
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 LEVONORGESTREL — the ingredient across all brands.

Top reported reactions

Device Expulsion45,536
Device Dislocation20,447
Menstruation Irregular15,061
Vaginal Haemorrhage15,056
Genital Haemorrhage11,164
Abdominal Pain Lower9,317
Nausea8,806

Age at onset

Neonate87
Infant54
Child25
Adolescent1,518
Adult62,663
Elderly189

Reporter sex

206,325 reports
Male · 1%
Female · 99%
Unknown · 0%

Serious outcomes

Hospitalization11,401
Disabling2,217
Life-threatening2,086
Death309
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,815 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.

About this NDC listing & data coverage

Finished prescription 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 — 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

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 Novel Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novel Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 40032-0450-11 · Novel 40032-0700-83 · Novel →
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.