Emergency Contraceptive Levonorgestrel 1.5 mg Tablet, 1 tablet — NDC 59726-138-01 (Billing 59726-0138-01)
by P & L Development, LLC · 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
This is a package of 1 tablet of Emergency Contraceptive Levonorgestrel 1.5 mg Tablet from P & L Development, LLC, no longer marketed (first marketed Aug 2023), no longer in the FDA NDC Directory. It is this product's only package size.
NDC 59726-0138-01
🏷️ FDA NDC (as labeled)
59726-138-01
billing pads the product segment with a zero
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
59726-138-01
Product NDC
59726-138
11-digit billing NDC
59726013801
RxCUI
483325
UNII
5W7SIA7YZW
UPC
0359726138017
Application #
ANDA205329
SPL Set ID
25676fc2-1f1f-40d2-8e84-3e52c8abda49
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
Discontinued
FDA listing status
Discontinued by firm (certified through Sep 2026)
Marketing start
2023-08-01
Route
ORAL
Dosage form
TABLET
Substance
LEVONORGESTREL
Quick answers
- RxCUI (RxNorm): 483325
Why two NDCs?
The FDA registers this code as 59726-138-01 — 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 → 59726-0138-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Levonorgestrel is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Levonorgestrel should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg...
Read the full MedlinePlus article ↗📗 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levonorgestrel — tap one for details:
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.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Levonorgestrel?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 59726-0138-01 You're viewing this Main listing | 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK | 2023-08-01 | — | Discontinued by firm |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 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 mgthis 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerP & L Development, LLC
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA205329 (ANDA)
Labeler code59726
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio124 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 Ask a Doctor or Pharmacist Before Use If
📄 When Using This Product
📄 Keep Out of Reach of Children
📄 Other Information
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
⏱️ Dosage and Administration ▾
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.
⚠️ Warnings ▾
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 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 you may have menstrual changes tiredness breast pain nausea headache vomiting lower stomach (abdominal) pain dizziness
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Levonorgestrel 1.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients croscarmellose sodium, lactrose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188
🎯 Purpose ▾
Purpose Emergency contraceptive
📄 Do Not Use ▾
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 ▾
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 ▾
When using this product you may have menstrual changes tiredness breast pain nausea headache vomiting lower stomach (abdominal) pain dizziness
📄 Keep Out of Reach of Children ▾
Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
📄 Other Information ▾
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 release egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation) do not use if package is open or blister seal is broken or missing store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
📄 Package Label / Principal Display Panel ▾
Principal display panel Compare to the active ingredient in Plan B One-Step®† emergency contraceptive levonorgestrel Tablet 1.5 mg one tablet. one step. the sooner you take it, the more effective it will be take as soon as possible within 72 hours (3 days) after unprotected sex will not harm an existing pregnancy reduces chance of pregnancy after unprotected sex not for regular birth control tablet 1.5 mg †This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One Step®.
Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590
Package Label READYinCASE Emergency Contraceptive Levonorgestrel 1.5 mg
No label section mentions that — try another word, or open the full label on DailyMed below.
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
Age at onset
Reporter sex
Male · 1%
Female · 99%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
P & L Development, LLC 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.
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.