Tilia Fe NdAc and EE Tablets and Ferrous Fumarate Kit — NDC 75907-0086-32 package photo

Tilia Fe NdAc and EE Tablets and Ferrous Fumarate Kit

by Dr. Reddys Laboratories Inc. · 3 BLISTER PACK in 1 CARTON (75907-086-32) / 1 KIT in 1 BLISTER PACK
NDC 75907-0086-32
🏷️ FDA NDC (as labeled) 75907-086-32 billing pads the product segment with a zero
This package
Contains1 kit in 1 blister pack Cost per ea$0.7879 NADAC Per package$2.36 / 3 kit Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.22/unit · Part D plans $1.74/unit — full pricing hub ↓
Also comes in: 1 packet 75907-0086-28
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) 75907-086-32
Product NDC 75907-086
11-digit billing NDC 75907008632
NCPDP billing unit EA — each (per item)
Application # ANDA202962
SPL Set ID 118fb017-b44d-4223-ac5a-501ca96de210
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-01
Dosage form KIT
GPI-14 25992003300340
GCN Seq No 030493
GCN 68105
HICL code 001454
Ingredient (HICL) Norethindrone-E.estradiol-Iron
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 TILIA FE 28 TABLET
FDB brand name Tilia Fe
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 75907-086-32 — 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 → 75907-0086-32. 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 Iron bivalent, oral preparations class.

Drug family (ATC) Iron bivalent, oral preparations
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

LabelerDr. Reddys Laboratories Inc.
Application holderNOVAST LABORATORIES LTD
FDA applicationANDA202962 (ANDA)
Labeler code75907
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio34 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 TILIA FE 28 TABLET Ingredient Norethindrone-E.estradiol-Iron
📖 What it is MedlinePlus · NLM

Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and norethindrone (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work mainly 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 ↗
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 yellow / brown
ShapeRound
ImprintF;N
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 $0.788 $2.36 / 3 kit
Medicaid paysCMS SDUD · 12 mo $1.22 $3.65 / 3 kit
Medicare drug plans payPart D · Q2 2026 $1.74 $5.21 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $1.127 $0.788
▼ Down 27% over the last 9 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
Tilia Fethis 75907-0086-32 Dr. 1 kit $0.788 AB Availability likely
Tilia Fe 51862-0896-01 Mayne 1 packet $1.012 AB FDA listed +29%
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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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 75907-0086-32, 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
2.2K
Units reimbursed last 4 qtrs
114.6K
Gross reimbursed last 4 qtrs
$139.3K
Avg / prescription
$63.13
Avg / unit
$1.2156
Latest quarter Q4 2025
568Rx
Medicaid pays / ea
$1.2156
gross reimbursed
vs
NADAC / ea
$0.7879
acquisition cost
=
Spread
+$0.4277
+54% 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
24% FFS 76% MCO
Fee-for-service · 538 Rx Managed care · 1,668 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 812 units · 10.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 476 units · 8.1 per 100k residents WI Michigan: 7,700 units · 76.7 per 100k residents MI New York: 9,408 units · 48.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,464 units · 58.2 per 100k residents OR Nevada: 756 units · 23.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,820 units · 14.5 per 100k residents IL Indiana: 6,188 units · 90.2 per 100k residents IN Ohio: 7,084 units · 60.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 3,696 units · 39.8 per 100k residents NJ Massachusetts: 7,364 units · 105 per 100k residents MA California: 29,534 units · 75.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,268 units · 50.1 per 100k residents KY West Virginia: no data reported WV Virginia: 3,668 units · 42.1 per 100k residents VA Maryland: 2,520 units · 40.8 per 100k residents 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: 4,480 units · 41.3 per 100k residents NC South Carolina: 2,828 units · 52.6 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 980 units · 21.4 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 4,928 units · 44.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,036 units · 3.4 per 100k residents TX Florida: 14,560 units · 64.4 per 100k residents FL
Units reimbursed · per 100k residents
3.4105
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 Massachusetts 105 /100k
2 Indiana 90.2 /100k
3 Michigan 76.7 /100k
4 California 75.8 /100k
5 Florida 64.4 /100k
6 Ohio 60.1 /100k
7 Oregon 58.2 /100k
8 South Carolina 52.6 /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 kit this page75907-0086-32 2,206 Rx · $139,275
1 packet75907-0086-28 No Medicaid data
Drug total (last 4 qtrs): 2,206 Rx · 114,570 units · $139,275 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 Tilia Fe — 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 Tilia Fe. 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
$6.1K
Claims incl. refills
63
Beneficiaries
40
Spend / beneficiary
$151.59
Spend / claim
$96.24
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
75907-0086-28 1 BLISTER PACK in 1 PACKET (75907-086-28) / 1 KIT in 1 BLISTER PACK $0.7879 / ea $0.79 2024-06-01 Active
75907-0086-32 You're viewing this 3 BLISTER PACK in 1 CARTON (75907-086-32) / 1 KIT in 1 BLISTER PACK $0.7879 / ea $2.36 2024-06-01 Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.7879 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 75907-0086-32?
NDC 75907-0086-32 is listed by the FDA — 3 blister pack in 1 carton / 1 kit in 1 blister pack.
What NDC number is used to bill for this package of Tilia Fe NdAc and EE Tablets and Ferrous Fumarate Kit?
Bill NDC 75907-0086-32 — the 11-digit billing format is 75907008632. 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 75907-086-32, 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: 75907-0086-32, written without dashes as 75907008632. 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 75907-0086-32, the first segment (75907) is the labeler code FDA assigned to Dr. Reddys Laboratories Inc.; the middle segment (0086) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (32) 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 Dr. Reddys Laboratories Inc.. 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 1 other package presentation of this same product, including 1 packet (75907-0086-28). 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?
Dr. Reddys Laboratories Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
🚨 Boxed Warning 63 words

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: Cigarette smoking increases the risk of serious cardiovascular side effects from combined oral contraceptive (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 Tilia Fe, are contraindicated in women who are over 35 years of age and smoke.

🎯 Indications and Usage ~3 min read

INDICATIONS AND USAGE Tilia Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months.

Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used.

Correct and consistent use of methods can result in lower failure rates. Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year.

United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method Typical Use 1 Perfect Use 2 (1) (2) (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Symptothermal 6 2 Post-ovulation 1 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4 Condom 8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only

0.5 Combined

0.1IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNG 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Norplant ® and Norplant-2 ® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75% 9 . Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 Source: Trussell J, The Essentials of Contraception.

In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology : Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant.

Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film.

6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides.

9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of combined oral c…

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION The tablet dispenser has been designed to make Tilia Fe dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets. Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen.

Six different day label stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label sticker that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 28-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Tilia Fe should be taken exactly as directed and at intervals not exceeding 24 hours. Tilia Fe provides a continuous administration regimen consisting of 21 active tablets (pale yellow, light yellow and light brown) and seven brown non-hormone containing tablets of ferrous fumarate.

The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no "off-tablet days." A. Sunday-Start Regimen: The patient begins taking the first pale yellow tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins.

When menstrual flow begins on Sunday, the first pale yellow is taken on the same day. The patient takes one active tablet daily for 21 days. The last light brown tablet in the dispenser will be taken on a Saturday.

Upon completion of all 21 active tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday active tablet in the top row. Adhering to this regimen of one active tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday.

B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self adhesive day label sticker that corresponds to her starting day over the preprinted days on the tablet dispenser.

She starts taking one active tablet daily, beginning with the first active tablet in the top row. After the last active tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last active tablet, again starting with the first tablet in the top row after placing the appropriate day label sticker over the preprinted days on the tablet dispenser.

Following this regimen of 21 active tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course. Tablets should be taken regularly at the same time each day and can be taken without regard to meals. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

Special Notes on Administration Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking active tablets, continue medication withou…

Contraindications 205 words

CONTRAINDICATIONS Combined oral contraceptives should not be used in women who currently have the following: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 • Have cerebrovascular disease • Have coronary artery disease • Have current or history of deep vein thrombosis or pulmonary embolism • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart • Have inherited or acquired hypercoagulopathies • Have uncontrolled hypertension or hypertension with vascular disease • Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches • Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or end-organ damage, or diabetes mellitus of > 20 years duration • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior pill use • Hepatic adenomas or carcinomas • Known or suspected pregnancy • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

⚠️ Warnings ~3 min read

WARNINGS The use of combined oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing combined oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used combined oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the combined oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies.

Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among combined oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between combined oral contraceptive users and nonusers.

The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from References 8 and 9 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods. 1.

Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction An increased risk of myocardial infarction has been attributed to combined oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.

The relative risk of heart attack for current combined oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30. Smoking in combination with combined oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases.

Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Figure 3) among women who use combined oral contraceptives. Combined oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism.

Combined oral contraceptives have been shown to increase blood pressure among users (see Section 10 in WARNINGS ). Similar effects on risk factors have been associated with an increased risk of heart disease. Combined oral contraceptives must be used with caution in women with cardiovascular disease risk factors. fig3 b.

Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of combined oral contraceptives is well established. Case control studies have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases an…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Post Marketing Experience 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 4). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 4). 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. 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.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): • Thrombophlebitis • Arterial thromboembolism • Pulmonary embolism • Myocardial infarction • Cerebral hemorrhage • Cerebral thrombosis • Hypertension • Gallbladder disease • Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of combined oral contraceptives, although additional confirmatory studies are needed: • Mesenteric thrombosis • Retinal thrombosis The following adverse reactions have been reported in patients receiving combined oral contraceptives and are believed to be drug-related: • Nausea • Vomiting • Gastrointestinal symptoms (such as abdominal cramps and bloating) • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea • Temporary infertility after discontinuation of treatment • Edema • Melasma which may persist • Breast changes: tenderness, enlargement, secretion • Change in weight (increase or decrease) • Change in cervical erosion and secretion • Diminution in lactation when given immediately postpartum • Cholestatic jaundice • Migraine • Rash (allergic) • Mental depression • Mood swings • Reduced tolerance to carbohydrates • Vaginal candidiasis • Change in corneal curvature (steepening) • Intolerance to contact lenses The following adverse reactions have been reported in users of combined oral contraceptives and the association has been neither confirmed nor refuted: • Pre-menstrual syndrome • Cataracts • Changes in appetite • Cystitis-like syndrome • Headache • Nervousness • Dizziness • Hirsutism • Loss of scalp hair • Erythema multiforme • Erythema nodosum • Hemorrhagic eruption • Vaginitis • Porphyria • Impaired renal function • Hemolytic uremic syndrome • Budd-Chiari syndrome • Acne • Changes in libido • Colitis fig4

🆘 Overdosage 32 words

OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of combined oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY ORAL CONTRACEPTION Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). In vitro and animal studies have shown that norethindrone combines high progestational activity with low intrinsic androgenicity.

In humans, norethindrone acetate in combination with ethinyl estradiol does not counteract estrogen-induced increases in sex hormone binding globulin (SHBG). Following multiple-dose administration of norethindrone acetate and ethinyl estradiol tablets, serum SHBG concentrations increase two- to three-fold and free testosterone concentrations decrease by 47% to 64%, indicating minimal androgenic activity. ACNE Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production.

While the combination of norethindrone acetate and ethinyl estradiol increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established. Pharmacokinetics Absorption Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, since the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone.

Norethindrone acetate and ethinyl estradiol are rapidly absorbed, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 2 hours post-dose. Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol. Administration of norethindrone acetate/ethinyl estradiol with a high fat meal decreases rate, but not extent,of ethinyl estradiol absorption.

The extent of norethindrone absorption is increased by 27% following administration with food. Plasma concentrations of norethindrone and ethinyl estradiol following chronic administration of norethindrone acetate and ethinyl estradiol tablets to 17 women are shown below ( Figure 1 ). Mean steady-state concentrations of norethindrone for the 1/20, 1/30, and 1/35 tablet strengths increased as ethinyl estradiol dose increased over the 21-day dose regimen, due to dose-dependent effects of ethinyl estradiol on serum SHBG concentrations ( Table 1 ).Mean steady-state plasma concentrations of ethinyl estradiol for the 1/20, 1/30, and 1/35 tablet strengths were proportional to ethinyl estradiol dose ( Table 1 ).

Distribution Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg. Plasma protein binding of both steroids is extensive (>95%); norethindrone binds to both albumin and sex hormone binding globulin, whereas ethinyl estradiol binds only to albumin. Although ethinyl estradiol does not bind to SHBG, it induces SHBG synthesis.

Norethindrone acetate and ethinyl estradiol tablets increase serum SHBG concentrations two- to three-fold ( Table 1 ). Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

A small amount of norethindrone acetate is metabolically converted to ethinyl estradiol. Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide. Sulfates are the major circulating conjugates of ethinyl estradiol and glucuronides predominate in urine.

The primary oxidative metabolite is 2-hydroxy ethinyl estradiol, formed by the CYP3A4 isoform of cytochrome P450. Part of the first-pass metabolism of…

📦 How Supplied / Storage and Handling 183 words

HOW SUPPLIED Tilia Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets and seven brown tablets in a blister card (NDC 75907-086-28) within a plastic dispenser. Each of the five pale yellow, biconvex, round tablets (debossed with "H2" on one side) contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol. The next seven light yellow, biconvex, round tablets (debossed with "H3" on one side) contain 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol.

The next nine light brown, biconvex, round tablets (debossed with "H4" on one side) contain 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol. The last seven brown, biconvex, round tablets (debossed with "F" on one side and " N " on the other side) each contain 75 mg ferrous fumarate. Tilia Fe Tablets are available in the following configurations: Carton of 3 compacts NDC 75907-086-32 Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Protect from light. REFERENCES AVAILABLE UPON REQUEST

📋 Description ~2 min read

DESCRIPTION Tilia Fe is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose.

Each pale yellow tablet contains 1 mg norethindrone acetate [(17 alpha)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake.

Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol.

Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide,Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), Iron Oxide Yellow, Iron Oxide Red, Iron Oxide Black. The structural formulas are as follows: Each brown tablet contains: Ferrous Fumarate, Micro-crystalline Cellulose, Hydroxypropyl Cellulose, Crospovidone, Magnesium Stearate, Polyvinyl Alcohol, Iron Oxide Yellow, Talc, Polyethylene Glycol 3350, Iron Oxide Red, Lecithin (Soya), Iron Oxide Black.

Each Tilia Fe tablet dispenser contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets, and seven brown tablets. These tablets are to be taken in the following order: one pale yellow tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light brown tablet each day for nine days, and then one brown tablet each day for seven days. structure

💬 Information for Patients 9 words

INFORMATION FOR THE PATIENT See patient labeling printed below.

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