Falmina levonorgestrel and ethinyl estradiol Kit, 1 packet — NDC 16714-0359-01 package photo

Falmina levonorgestrel and ethinyl estradiol Kit, 1 packet

by Northstar Rx LLC · 1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK
NDC 16714-0359-01
🏷️ FDA NDC (as labeled) 16714-359-01 billing pads the product segment with a zero
This package
Contains1 packet Cost per ea$0.1509 NADAC Per package$0.15 / 1 kit Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.3250/unit · Part D plans $0.2100/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 16714-359-01
Product NDC 16714-359
11-digit billing NDC 16714035901
NCPDP billing unit EA — each (per item)
Application # ANDA090721
SPL Set ID cf6f069e-4b78-4adb-b5be-100b9d85aab7
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-13
Dosage form KIT
GPI-14 25990002400305
GPI class Falmina
GCN Seq No 030986
GCN 11534
HICL code 001460
Ingredient (HICL) Levonorgestrel/Ethin.estradiol
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 FALMINA-28 TABLET
FDB brand name Falmina
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 16714-359-01 — 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 → 16714-0359-01. 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 Estrogen class.

Pharmacologic class Estrogen
Drug family (ATC) Progestogens and estrogens, sequential preparations, Natural and semisynthetic estrogens, plain, Estrogens
How it works Estrogen Receptor Agonists
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.

🏭 Manufacturer & labeler

LabelerNorthstar Rx LLC
Application holderNOVAST LABORATORIES LTD
FDA applicationANDA090721 (ANDA)
Labeler code16714
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio414 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.

🩺 Clinical

Label name FALMINA-28 TABLET Ingredient Levonorgestrel/Ethin.estradiol
📖 What it is MedlinePlus · NLM

Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and levonorgestrel (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It prevents pregnancy mainly by stopping your ovaries from releasing an egg. It also thickens the cervical mucus so sperm can't easily get through, and changes the uterine lining a...
  • What exactly does this medication do, and how well does it work?
  • The most common ones in the first few months are headaches, nausea, irregular bleeding or spotting, breast tenderness, and mood changes. Most of these tend to settle down after you...
  • Are there any side effects I should expect when I first start?
📖 Read our full Ethinyl Estradiol / Levonorgestrel guide →
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.

💊 What it looks like

Color Orange / White
ShapeRound
ImprintA3
Size5 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 $0.151 $0.15 / 1 kit
Medicaid paysCMS SDUD · 12 mo $0.3250 $0.33 / 1 kit
Medicare drug plans payPart D · Q2 2026 $0.2100 $0.21 / 1 kit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.248 $0.151
▼ Down 25% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Altavera 70700-0116-85 Xiromed, 1 kit $0.113 AB Availability likely save 25%
Ayuna 65862-0848-88 Aurobindo 3 pouches $0.113 AB Availability likely save 25%
Levonorgestrel And Ethinyl Estradiol 00378-6550-53 Mylan 3 pouches $0.113 AB Discontinued save 25%
Chateal EQ 50102-0230-23 Afaxys 3 pouches $0.113 AB Availability likely save 25%
Marlissa 68462-0388-29 Glenmark 1 kit $0.113 AB Availability likely save 25%
Kurvelo 68180-0844-73 Lupin 63 tablets $0.113 AB Availability likely save 25%
Portia 00555-9020-58 Teva 6 pouches $0.113 Availability likely save 25%
Daysee 68180-0846-13 Lupin 2 pouches $0.125 AB Availability likely save 17%
Levora 51862-0097-06 Mayne 1 kit $0.145 AB Discontinued save 4%
Lessina 00555-9014-67 Teva 3 pouches $0.151 Availability likely
Aubra EQ 50102-0220-23 Afaxys 3 pouches $0.151 AB1 Availability likely
Levonorgestrel and Ethinyl Estradiol 68180-0854-73 Lupin 1 kit $0.151 AB1 Availability likely
Levonorgestrel And Ethinyl Estradiol 00378-7287-53 Mylan 3 pouches $0.151 AB1 Availability likely
Aviane 00555-9045-58 Teva 6 pouches $0.151 Availability likely
Vienva 70700-0118-85 Xiromed, 1 kit $0.151 AB1 Availability likely
Falminathis 16714-0359-01 Northstar 1 packet $0.151 AB1 Availability likely
Lutera 51862-0028-06 Mayne 1 kit $0.152 AB1 Discontinued +1%
Sronyx 51862-0545-06 Mayne 1 kit $0.174 AB2 Discontinued +15%
Introvale 70700-0117-87 Xiromed, 1 kit $0.184 AB FDA listed +22%
Setlakin 16714-0366-03 Northstar 3 pouches $0.221 AB Availability likely +46%
Levonorgestrel and Ethinyl Estradiol 68180-0843-13 Lupin 1 kit $0.221 AB Availability likely +46%
levonorgestrel and ethinyl estradiol 68462-0672-95 Glenmark 3 pouches $0.221 AB Availability likely +46%
Afirmelle 65862-0849-88 Aurobindo 3 pouches $0.225 AB1 FDA listed +49%
Iclevia 65862-0865-83 Aurobindo 3 pouches $0.227 AB FDA listed +50%
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 Lupin 2 pouches $0.239 AB Availability likely +59%
Levonest 16714-0340-01 Northstar 1 packet $0.339 AB Availability likely +125%
Levonorgestrel and Ethinyl Estradiol 68180-0857-73 Lupin 1 kit $0.339 AB Availability likely +125%
Tyblume 00642-7471-01 Exeltis 1 kit $0.828 Availability likely +448%
levonorgestrel and ethinyl estradiol 42192-0623-03 Acella 1 kit $3.442 AB3 Availability likely +2181%
Levonest 50090-2505-00 A-S 1 kit AB FDA listed
Kurvelo 50090-6374-00 A-S 21 tablets AB FDA listed
Altavera 63629-2343-01 Bryant 1 kit AB FDA listed
Lutera 55741-0005-06 Dr. 1 kit AB1 FDA listed
Balcoltra 75854-0602-02 Avion 1 kit AB3 FDA listed
Vienva Tm 50090-5580-00 A-S 1 kit AB1 FDA listed
Levonorgestrel and Ethinyl Estradiol 79929-0003-07 Naari 1 kit AB FDA listed
Levonorgestrel and Ethinyl Estradiol 60505-4898-08 Apotex 1 kit AB1 FDA listed
Levonorgestrel and Ethinyl Estradiol 60505-4899-08 Apotex 1 kit AB FDA listed
Vienva TM 63629-2344-01 Bryant 1 kit AB1 FDA listed
Levonorgestrel and Ethinyl Estradiol 79929-0004-07 Naari 1 kit AB1 FDA listed
Aviane 63187-0889-28 Proficient 1 pouch 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
Sep 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 16714-0359-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12
Units reimbursed last 4 qtrs
672
Gross reimbursed last 4 qtrs
$218.39
Avg / prescription
$18.20
Avg / unit
$0.3250
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.3250
gross reimbursed
vs
NADAC / ea
$0.1509
acquisition cost
=
Spread
+$0.1741
+115% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% FFS
Fee-for-service · 12 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 672 units · 3.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.43.4
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 3.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.
1 kit16714-0359-03 15,928 Rx · $254,361
1 kit16714-0359-04 10,030 Rx · $157,998
1 kit16714-0359-02 No Medicaid data
Drug total (last 4 qtrs): 25,970 Rx · 1,403,109 units · $412,577 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 Falmina — 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 Falmina. 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
$18.9K
Claims incl. refills
835
Beneficiaries
451
Spend / beneficiary
$41.90
Spend / claim
$22.63
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
16714-0359-01 You're viewing this 1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK $0.1509 / ea $0.15 2013-09-13 Active
16714-0359-02 1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACK 2013-09-13 Active
16714-0359-03 3 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACK $0.1509 / ea $0.45 2013-09-13 Active
16714-0359-04 6 BLISTER PACK in 1 CARTON (16714-359-04) / 1 KIT in 1 BLISTER PACK $0.1509 / ea $0.91 2013-09-13 Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.1509 NADAC).

Pack size FAQ

What quantity is in NDC 16714-0359-01?
NDC 16714-0359-01 contains 1 packet — 1 blister pack in 1 packet / 1 kit in 1 blister pack.
What is the difference between NDC 16714-0359-01 and NDC 16714-0359-02?
Both are Falmina levonorgestrel and ethinyl estradiol Kit — the drug itself is identical. NDC 16714-0359-01 is the 1 packet package, while NDC 16714-0359-02 is the 1 kit package.
What NDC number is used to bill for this package of Falmina levonorgestrel and ethinyl estradiol Kit?
Bill NDC 16714-0359-01 — the 11-digit billing format is 16714035901. 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.

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
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) ✓ Available
“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

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 FDA registers it as 16714-359-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 16714-0359-01, written without dashes as 16714035901. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 16714-0359-01, the first segment (16714) is the labeler code FDA assigned to Northstar Rx LLC; the middle segment (0359) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Northstar Rx LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 kit (16714-0359-02), 1 kit (16714-0359-03), 1 kit (16714-0359-04). 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?
Northstar Rx 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 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 192 words

INDICATIONS AND USAGE FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported.

This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles.

Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m 2 . Females with a BMI greater than 30 kg/m 2 accounted for 12.1% (n=179) of the study population.

Females with a BMI over 35 kg/m 2 accounted for 4.3% (n=63) of the study population.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, FALMINA™ (levonorgestrel and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of FALMINA is one orange tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that FALMINA tablets be taken at the same time each day.

During The First Cycle Of Use The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking FALMINA on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start). Sunday start: The patient is instructed to begin taking FALMINA on the first Sunday after the onset of menstruation.

If menstruation begins on a Sunday, the first tablet (orange) is taken that day. One orange tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started.

During the first cycle, contraceptive reliance should not be placed on FALMINA until an orange tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days. Day 1 start: During the first cycle of medication, the patient is instructed to begin taking FALMINA during the first 24 hours of her period (day one of her menstrual cycle). One orange tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days.

Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If FALMINA tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on FALMINA tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during those 7 days.

After the first cycle of use The patient begins her next and all subsequent courses of tablets on the day after taking her last white tablet. She should follow the same dosing schedule: 21 days on orange tablets followed by 7 days on white tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken an orange tablet daily for 7 consecutive days.

Switching from another hormonal method of contraception When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts FALMINA. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen.

When the patient is switching from a 28-day regimen of tablets, she should start her first pack of FALMINA on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin FALMINA the next day.

If switching from an implant or injection, the patient should start FALMINA on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, implant, or intrauterine system (IUS), the patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days of the first pack. If spotting or breakthrough bleeding occurs If spotting or breakthrough bleeding occur, the patient is ins…

Contraindications 158 words

CONTRAINDICATIONS Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders A history of deep-vein thrombophlebitis or thromboembolic disorders Cerebrovascular or coronary artery disease (current or past history) Valvular heart disease with thrombogenic complications Thrombogenic rhythm disorders Hereditary or acquired thrombophilias Prolonged immobilization (especially with major surgery) Diabetes with vascular involvement Headaches with focal neurological symptoms or migraine with aura Women with migraine who are 35 years or older Uncontrolled hypertension Known or suspected carcinoma of the breast or personal history of breast cancer Known or suspected estrogen-or progesterone sensitive malignancy Undiagnosed abnormal vaginal bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas, or active liver disease Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

⚠️ Warnings 62 words

WARNINGS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including FALMINA, are contraindicated in women who are over 35 years of age and smoke.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.

The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. FIGURE 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following adverse reactions associated with the use of oral CHCs were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.

Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders: Abdominal bloating, vomiting General disorders and administration site conditions: Edema, fluid retention Hepatobiliary disorders: Cholestatic jaundice Pyschiatric disorders: Change in libido, mood changes Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders: Acne, melasma Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins figure2

🆘 Overdosage 39 words

OVERDOSAGE Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mode of Action Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation. Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of FALMINA (Levonorgestrel and Ethinyl Estradiol Tablets, USP) in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism.

Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%. After a single dose of levonorgestrel and ethinyl estradiol tablets to 22 women under fasting conditions, maximum serum concentrations of levonorgestrel are 2.8 ± 0.9 ng/mL (mean ± SD) at 1.6 ± 0.9 hours. At steady state, attained from day 19 onwards, maximum levonorgestrel concentrations of 6.0 ± 2.7 ng/mL are reached at 1.5 ± 0.5 hours after the daily dose.

The minimum serum levels of levonorgestrel at steady state are 1.9 ± 1.0 ng/mL. Observed levonorgestrel concentrations increased from day 1 (single dose) to days 6 and 21 (multiple doses) by 34% and 96%, respectively (Figure 1). Unbound levonorgestrel concentrations increased from day 1 to days 6 and 21 by 25% and 83%, respectively.

The kinetics of total levonorgestrel are non-linear due to an increase in binding of levonorgestrel to sex hormone binding globulin (SHBG), which is attributed to increased SHBG levels that are induced by the daily administration of ethinyl estradiol. Following a single dose, maximum serum concentrations of ethinyl estradiol of 62 ± 21 pg/mL are reached at 1.5 ± 0.5 hours. At steady state, attained from at least day 6 onwards, maximum concentrations of ethinyl estradiol were 77 ± 30 pg/mL and were reached at 1.3 ± 0.7 hours after the daily dose.

The minimum serum levels of ethinyl estradiol at steady state are 10.5 ± 5.1 pg/mL. Ethinyl estradiol concentrations did not increase from days 1 to 6, but did increase by 19% from days 1 to 21 (Figure 1). FIGURE 1 Mean (SE) levonorgestrel and ethinyl estradiol serum concentrations in 22 subjects receiving 100 mcg levonorgestrel and 20 mcg ethinyl estradiol TABLE 1 provides a summary of levonorgestrel and ethinyl estradiol pharmacokinetic parameters. table1 figure1 Distribution Levonorgestrel in serum is primarily bound to SHBG.

Ethinyl estradiol is about 97% bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Metabolism Levonorgestrel: The most important metabolic pathway occurs in the reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation.

Most of the metabolites that circulate in the blood are sulfates of 3α, 5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides. Some of the parent levonorgestrel also circulates as 17β-sulfate. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

Ethinyl estradiol: Cytochrome P450 enzymes (CYP3A4) in the liver are responsible for the 2-hydroxylation that is the major oxidative reaction. The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion. Levels of Cytochrome P450 (CYP3A) vary widely among individuals and can explain the variation in rates of ethinyl estradiol 2-hydroxylation.

Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and undergoes enterohepatic circulation. Excretion The elimination half-life for levonorgestrel is approximately 36 ± 13 hours at steady state. Levonorgestrel and its metabolites are primarily excreted in the urine (40% to 68%) and about 16% to 48% are excreted in feces.

The elimination half-li…

📦 How Supplied / Storage and Handling ~3 min read

HOW SUPPLIED FALMINA™ (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.1 mg/0.02 mg) is available in a compact blister card (NDC 16714-359-01), containing 28 tablets arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows: 21 active tablets: orange, round tablet debossed with "A3" on one side. 7 inert tablets: white, round tablet debossed with "P" on one side and " N " on the other side. FALMINA Tablets are available in the following configuations: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP controlled room temperature].

Manufactured for: Northstar Rx LLC Memphis TN 38141 Manufactured by: Novast Laboratories Ltd. Nantong, China 226009 I 0017 Rev. C Rev.

02/2025 Brief Summary Patient Package Insert This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. Oral contraceptives, also known as "birth-control pills" or "the pill", are taken to prevent pregnancy, and when taken correctly, have a failure rate of approximately 1.0% per year (1 pregnancy per 100 women per year of use) when used without missing any pills.

The average failure rate of large numbers of pill users is approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.

For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you: smoke. have high blood pressure, diabetes, high cholesterol, or a tendency to form blood clots. have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, malignant or benign liver tumors, or major surgery with prolonged immobilization. have headaches with neurological symptoms.

You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Although cardiovascular disease risks may be increased with oral-contraceptive use after age 40 in healthy, nonsmoking women, there are also greater potential health risks associated with pregnancy in older women. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

For this reason, COCs, including FALMINA, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS). Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses.

These side effects, especially nausea and vomiting, may subside within the first three months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill: 1.

Blood clots in the legs (thrombophle…

📋 Description 91 words

DESCRIPTION 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch. structure

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