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Morning After Levonorgestrel 1.5 mg/1.5mg Tablet, 1 mg — NDC 69953-0515-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Morning After Levonorgestrel 1.5 mg/1.5mg Tablet, 1 mg — NDC 69953-515-01 (Billing 69953-0515-01)

by Rapha Pharmaceuticals, Inc. · 1 BLISTER PACK in 1 CARTON / 1 mg in 1 BLISTER PACK

This is a package of 1 mg of Morning After Levonorgestrel 1.5 mg/1.5mg Tablet from Rapha Pharmaceuticals, Inc., marketed since Mar 2018 and currently FDA-listed. It is this product's only package size.

NDC 69953-0515-01
🏷️ FDA NDC (as labeled) 69953-515-01 billing pads the product segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69953-515-01
Product NDC 69953-515
11-digit billing NDC 69953051501
RxCUI 483325, 1657617
UNII 5W7SIA7YZW
UPC 0369953515017
Application # ANDA206867
SPL Set ID 677aa953-3c30-4ce5-e053-2991aa0ab2b2
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 2018-03-22
Route ORAL
Dosage form TABLET
Substance LEVONORGESTREL
Quick answers
  • RxCUI (RxNorm): 483325
Why two NDCs? The FDA registers this code as 69953-515-01 — 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 → 69953-0515-01. 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.

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

📖 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.

🧪 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
69953-0515-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 1 mg in 1 BLISTER PACK 2018-03-22 — 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 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/1.5mgthis 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 —
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
Mar 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

LabelerRapha Pharmaceuticals, Inc.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA206867 (ANDA)
Labeler code69953
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio6 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 💬 Patient Medication Information 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 121 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 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 nausea lower stomach (abdominal) pain tiredness headache dizziness breast pain vomiting 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.

🧪 Active Ingredient 10 words ▾

DRUG FACTS Active ingredient Levonorgestrel 1.5 mg PURPOSE Emergency contraceptive

🧪 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

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Morning After® (levonorgestrel tablet, 1.5 mg) Emergency Contraceptive One Tablet. One Step. What You Need to Know What is Morning After®?

Morning After® 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 Morning After® is not.

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

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

Morning After® 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 Morning After®. 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 Morning After® 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 Morning After® work?

Morning After® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Morning After® 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 Morning After® 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 Morning After®? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex.

The sooner you take Morning After®, the better it works. How effective is Morning After®? If Morning After® 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 Morning After® worked? You will know Morning After® 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, Morning After® 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 Morning After®?

If you have questions or need more information, call our toll-free number at 1-855-274-4122. Other Information Keep out of reach of children: In case of overdose, get medical help or contact a… [Excerpted — this section continues on DailyMed.]

📄 Ask a Doctor 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 37 words ▾

DO NOT USE if you are already pregnant (because it will not work) for regular birth control

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.

📄 Other Information 73 words ▾

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 tear strip is removed or the blister seal is broken or missing store at 20° to 25°C (68° to 77°F)

📄 Questions or Comments 17 words ▾

QUESTIONS? Call 1-855-274-4122 Mfg for Rapha Pharmaceuticals, Inc. Orlando, Florida 32819 USA Made in India Code: TS/DRUGS/22/2009

📄 Package Label / Principal Display Panel 81 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -

1.5MG (1 TABLET CARTON LABEL) NDC 69953-515-01 Morning After® (levonorgestrel tablet 1.5 mg) Emergency Contraceptive Reduces chance of pregnancy after unprotected sex. Contains 1 Tablet Levonorgestrel 1.5 mg Not for regular birth control. 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 New! Now Available Over The Counter Morning After

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.

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 Rapha Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rapha Pharmaceuticals, 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.
← 69951-0004-16 · Prevention 69953-0516-01 · Rapha →
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.