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EContra One-Step Levonorgestrel 1.5 mg Tablet, 6-count — NDC 50102-0211-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EContra One-Step Levonorgestrel 1.5 mg Tablet, 6-count — NDC 50102-211-16 (Billing 50102-0211-16)

by Afaxys Pharma, LLC · 6 CARTON in 1 PACKAGE / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 6 tablets of EContra One-Step Levonorgestrel 1.5 mg Tablet from Afaxys Pharma, LLC, no longer marketed (first marketed Feb 2018), no longer in the FDA NDC Directory; retail pharmacies pay about $6.33 per tablet (NADAC).

NDC 50102-0211-16
🏷️ FDA NDC (as labeled) 50102-211-16 billing pads the product segment with a zero
This package
Contains6-count Cost per ea$6.33 NADAC Per package$37.98 / 6 tablet Pack sizes2 compare ↓
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. 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) 50102-211-16
Product NDC 50102-211
11-digit billing NDC 50102021116
NCPDP billing unit EA — each (per item)
RxCUI 483325, 1600602
UNII 5W7SIA7YZW
Application # ANDA206867
SPL Set ID 94b23c49-dfba-4a70-ada5-e5c212e703c5
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
Marketing start 2018-02-08
Route ORAL
Dosage form TABLET
Substance LEVONORGESTREL

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

GPI-14 25400040000340
GPI class EContra One-Step
GCN Seq No 058193
GCN 23549
HICL code 007318
Ingredient (HICL) Levonorgestrel
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name ECONTRA ONE-STEP 1.5 MG TABLET
FDB brand name Econtra One-Step
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 058193
  • GCN: 23549
  • GPI-14 (Medi-Span): 25400040000340
  • HICL (First Databank): 007318
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 483325
Why two NDCs? The FDA registers this code as 50102-211-16 — 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 → 50102-0211-16. 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

Label name ECONTRA ONE-STEP 1.5 MG TABLET Ingredient Levonorgestrel
📖 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.
📖 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $6.331 $37.98 / 6 tablet
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.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $10.215 $6.318
▼ Down 30% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
50102-0211-13 50102-211-13 Main listing 3 CARTON in 1 PACKAGE / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK $6.33 / ea $18.99 2020-10-27 — Active
50102-0211-16 You're viewing this 6 CARTON in 1 PACKAGE / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK $6.33 / ea $37.98 2018-02-08 — Discontinued by firm

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($6.33 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 6-count package — 6 carton in 1 package / 1 blister pack in 1 carton / 1 tablet in 1 blister pack.
How does this package differ from NDC 50102-0211-13?
Both are EContra One-Step Levonorgestrel 1.5 mg Tablet — the drug itself is identical. This page's package is the 6-count one, while NDC 50102-0211-13 is the 3 tablets package.
What NDC number is used to bill for this package of EContra One-Step Levonorgestrel 1.5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 mgthis 50102-0211-16 Afaxys 6 tablets $6.331 — Discontinued —
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 +7%
Opcicon One-Step 1.5 mg 62756-0718-60 Sun 1 tablet $6.797 — FDA listed +7%
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 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

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color White
ShapeRound
ImprintS;11
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

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

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 8I089SAH3T
    A carbohydrate powder extracted from potatoes. It serves as a filler to add bulk and volume to the tablet or capsule, and as a disintegrant to help the medicine break apart and release its active ingredient in your body.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescolloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch and talc.

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

LabelerAfaxys Pharma, LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA206867 (ANDA)
Labeler code50102
First marketedFeb 2018
Product typeHuman Otc Drug
Portfolio11 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 label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, 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.
🎯 Indications and Usage 23 words ▾

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 47 words ▾

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 31 words ▾

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

🧪 Active Ingredient 10 words ▾

Drug Facts Active ingredient (in each tablet) Levonorgestrel 1.5 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch and talc.

🎯 Purpose 3 words ▾

Purpose Emergency contraceptive

💬 Information for Patients ~3 min read ▾

Patient Information EContra One-Step ® (Levonorgestrel) Tablet, 1.5 mg Emergency Contraceptive One Tablet. One Step. What You Need to Know What is EContra One-Step ® ?

EContra One-Step ® 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 EContra One-Step ® is not.

EContra One-Step ® will not work if you are already pregnant and will not affect an existing pregnancy. EContra One-Step ® will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs). When should I use EContra One-Step ® ?

The sooner you take emergency contraception, the better it works. You should use EContra One-Step ® within 72 hours (3 days) after you have had unprotected sex . EContra One-Step ® 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 EContra One-Step ® .

EContra One-Step ® 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 EContra One-Step ® . 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 EContra One-Step ® 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 EContra One-Step ® work?

EContra One-Step ® works before release of an egg from the ovary. As a result, EContra One-Step ® usually stops or delays the release of an egg from the ovary. EContra One-Step ® is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy.

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

How effective is EContra One-Step ® ? If EContra One-Step ® 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 EContra One-Step ® worked? You will know EContra One-Step ® 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, EContra One-Step ® 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 about EContra One-Step ® ? If you have questions or need more information, call our toll-free number Afaxys Pharma, LLC at 1-855-888-2467.

Other Information Keep out of reach of children: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Do not use if the blister seal is opened. Store… [Excerpted — this section continues on DailyMed.]

📄 Do Not Use 17 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 31 words ▾

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 22 words ▾

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.

📄 Questions or Comments 27 words ▾

Questions? Call 1-855-888-2467 Manufactured for: Afaxys Pharma, LLC Charleston, SC, 29403, USA Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahabubnagar (Dt)-509302, India Made in India Code: TS/DRUGS/22/2009

📄 Package Label / Principal Display Panel 103 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg (3 Blister Carton Label) † Compares to the active ingredient of Plan B One-Step ® NDC 50102-211-13 EMERGENCY CONTRACEPTIVE EContra One-Step ® (Levonorgestrel) Tablet, 1.5 mg Reduces chance of pregnancy after unprotected sex. Not for regular birth control. 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. 1 Tablet 1.5 mg One Tablet.

One Step. afaxys ® 3 Mono Cartons of 1 Tablet Each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg (6 Blister Carton Label)

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
3 tablets50102-0211-13 28,315 Rx · $1,773,418
Drug total (last 4 qtrs): 28,326 Rx · 44,698 units · $1,773,536 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for 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 EContra One-Step (this brand).

Top reported reactions

Nausea204
Headache178
Genital Haemorrhage160
Dizziness138
Fatigue135
Abdominal Pain134
Vaginal Haemorrhage131

Age at onset

Neonate19
Infant11
Child4
Adolescent56
Adult721
Elderly1

Reporter sex

3,386 reports
Male · 1%
Female · 99%
Unknown · 0%

Serious outcomes

Hospitalization641
Life-threatening132
Disabling99
Death56
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 471 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

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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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

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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 3 tablets (50102-0211-13). 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?
Afaxys Pharma, 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.