AUROVELA Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Kit, 5 pouches — NDC 65862-941-58 (Billing 65862-0941-58)
This is a package of 5 pouches of AUROVELA Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Kit from Aurobindo Pharma Limited, marketed since Jun 2017 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 65862-941-58 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 65862 labeler · 941 product · 58 package
- Package marketed since
- Jun 15, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6586294158 9
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003300
- GCN: 68101
- GPI-14 (Medi-Span): 25990003610320
- HICL (First Databank): 001454
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 259176
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Iron bivalent, oral preparations class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 65862-0941-58 You're viewing this | 5 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | — | — | 2017-06-15 | — | Active |
| 65862-0941-88 65862-941-88 Main listing | 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | $0.1419 / ea | $0.43 | 2017-06-15 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 65862-0941-88?
What NDC number is used to bill for this package of AUROVELA Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Kit?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tarina Fe 1/20 EQ 50102-0228-23 | Afaxys | 3 pouches | $0.129 | AB | Availability likely | — |
| HAILEY Fe 1/20 68462-0419-29 | Glenmark | 1 kit | $0.129 | AB | Availability likely | — |
| Junel Fe 28 Day 00555-9026-58 | Teva | 6 pouches | $0.129 | AB | Availability likely | — |
| Hailey Fe 1.5/30 68462-0503-29 | Glenmark | 3 pouches | $0.142 | AB | Availability likely | — |
| Junel Fe 28 Day 00555-9028-58 | Teva | 6 pouches | $0.142 | AB | Availability likely | — |
| Junel Fe 24 00093-5328-62 | Teva | 3 pouches | $0.175 | AB | Availability likely | — |
| Tarina 24 Fe 50102-0224-23 | Afaxys | 3 pouches | $0.175 | AB | Availability likely | — |
| Finzala 00093-8210-62 | Teva | 12 tablets | $0.304 | AB | Availability likely | — |
| Charlotte 24Fe 68462-0852-29 | Glenmark | 1 kit | $0.304 | AB | Availability likely | — |
| norethindrone acetate and ethinyl estradiol and ferrous fumarate 68462-0376-29 | Glenmark | 1 kit | $0.422 | AB | FDA listed | — |
| Melodetta 24 Fe 69238-1031-07 | Amneal | 1 kit | $0.422 | — | FDA listed | — |
| Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate 00378-7303-53 | Mylan | 21 tablets | $0.788 | AB | Availability likely | — |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate 68462-0849-29 | Glenmark | 24 capsules | $0.962 | AB | Availability likely | — |
| Loestrin Fe 28 Day 51285-0125-70 | Teva | 5 pouches | $8.232 | AB | Availability likely | — |
| Junel Fe 28 Day 50090-3237-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate 60219-1031-07 | Amneal | 1 kit | — | — | FDA listed | — |
| Aurovela 24 Fe 65862-0934-58 | Aurobindo | 5 pouches | — | AB | FDA listed | — |
| Aurovela Fe 1/20 65862-0940-58 | Aurobindo | 5 pouches | — | AB | FDA listed | — |
| AUROVELA Fethis 65862-0941-58 | Aurobindo | 5 pouches | — | AB | FDA listed | — |
| Junel Fe 28 Day 50090-3122-00 | A-S | 6 pouches | — | AB | FDA listed | — |
| Junel Fe 28 Day 63629-5628-01 | Bryant | 6 pouches | — | AB | FDA listed | — |
| Oshih 59651-0504-88 | Aurobindo | 3 pouches | — | — | FDA listed | — |
| Loestrin Fe 28 Day 51285-0128-70 | Teva | 5 pouches | — | AB | FDA listed | — |
| Junel Fe 28 Day 72789-0450-79 | PD-Rx | 1 pouch | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Aurobindo Pharma Limited labeler code 65862
- Aurovela 1.5/30 Norethindrone Acetate and Ethinyl Estradiol 1.5 mg; 30 ug Tablet NDC 65862-935-54
- Paricalcitol 1 ug Capsule, Liquid Filled NDC 65862-936-30
- Paricalcitol 2 ug Capsule, Liquid Filled NDC 65862-937-30
- Paricalcitol 4 ug Capsule, Liquid Filled NDC 65862-938-30
- Aurovela 1/20 Norethindrone Acetate and Ethinyl Estradiol 1 mg; 20 ug Tablet NDC 65862-939-54
- Aurovela Fe 1/20 Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Kit NDC 65862-940-58
- LEVALBUTEROL 1.25 mg/.5mL Solution, Concentrate NDC 65862-942-03
- Levalbuterol .31 mg/3mL Solution NDC 65862-943-24
- Levalbuterol .63 mg/3mL Solution NDC 65862-944-24
- Levalbuterol 1.25 mg/3mL Solution NDC 65862-945-24
- Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL; 5 mg/mL Solution/ Drops NDC 65862-946-01
- Dorzolamide Hydrochloride and Timolol Maleate Preservative Free 20 mg/mL; 5 mg/mL Solution/ Drops NDC 65862-947-18
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Aurovela Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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 I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. * The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. ** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. *** N/A - Data not available. % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected* Typical** (No contraception) Oral contraceptives Combined progestin only Diaphragm with spermicidal cream or jelly Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) Vaginal Sponge nulliparous parous Implant Injection: depot medroxyprogesterone acetate IUD progesterone T copper T 380A LNg 20 Condom without spermicides female male Cervical Cap with spermicidal cream or jelly nulliparous parous Periodic abstinence (all methods) Withdrawal Female sterilization Male sterilization (85) 0.1 0.5 6 6 9 20 0.05 0.3 1.5 0.6 0.1 5 3 9 26 1 to 9 4 0.5 0.1 (85) 3 N/A*** N/A*** 20 26 20 40 0.05 0.3 2 0.8 0.1 21 14 20 40 25 19 0.5 0.15
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The blister pack has been designed to make oral contraceptive 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 blister pack above the first row of tablets. Note: Each blister pack 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. To achieve maximum contraceptive effectiveness, Aurovela Fe 1.5/30 should be taken exactly as directed and at intervals not exceeding 24 hours. Aurovela Fe 1.5/30 provides a continuous administration regimen consisting of 21 white to off-white tablets of norethindrone acetate and ethinyl estradiol and 7 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 white to off-white tablet from the top row of the blister pack (labeled Sunday) on the first Sunday after menstrual flow begins.
When the menstrual flow begins on Sunday, the first white to off-white tablet is taken on the same day. The patient takes one white to off-white tablet daily for 21 days. The last white to off-white tablet in the blister pack will be taken on a Saturday.
Upon completion of all 21 white to off-white 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 white to off-white tablet in the top row. Adhering to this regimen of one white to off-white tablet daily for 21 days, followed without interruption by one brown tablet daily for seven 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 blister pack.
She starts taking one white to off-white tablet daily, beginning with the first white to off-white tablet in the top row. After the last white to off-white 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 white to off-white tablet, again starting with the first tablet in the top row after placing the appropriate day label sticker over the preprinted days on the blister pack.
Following this regimen of 21 white to off-white 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 with a meal or at bedtime. 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… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Oral contraceptives are contraindicated in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular or coronary artery disease Current diagnosis of, or history of, breast cancer, which may be hormone sensitive Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas 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 ▾
WARNINGS The use of 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 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 oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the 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 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 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 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 oral contraceptive users has been estimated to be two to six (10 to 16). The risk is very low under the age of 30. Smoking in combination with 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 (17).
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 (Table II) among women who use oral contraceptives. TABLE II CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE Adapted from P.M. Layde and V.
Beral, Reference 18. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity (19). In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism (20 to 24).
Oral contraceptives have been shown to increase blood pressure among users (see section 9 in WARNINGS ). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. b.
Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users 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 (9, 10, 25 to 30).… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 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 to 1.12 (Figure 1) (70 to 74).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1) (70,73,75). 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 to 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 to 10 years of COC use. FIGURE 1: 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. There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving 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) Depression 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 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 FIGURE 1: RELEVANT STUDIES OF RISK OF BREAST CANCER WITH COMBINED ORAL CONTRACEPTIVES
🆘 Overdosage ▾
OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. NON-CONTRACEPTIVE HEALTH BENEFITS The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol (76 to 81).
Effects on menses: Increased menstrual cycle regularity Decreased blood loss and decreased incidence of iron deficiency anemia Decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: Decreased incidence of functional ovarian cysts Decreased incidence of ectopic pregnancies Effects from long-term use: Decreased incidence of fibroadenomas and fibrocystic disease of the breast Decreased incidence of acute pelvic inflammatory disease Decreased incidence of endometrial cancer Decreased incidence of ovarian cancer
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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). Pharmacokinetics The pharmacokinetics of Aurovela Fe 1.5/30 has not been characterized; however, the following pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the literature.
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 (1). Norethindrone acetate and ethinyl estradiol are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol (1 to 3). Distribution Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg (1 to 3).
Plasma protein binding of both steroids is extensive (greater than 95%); norethindrone binds to both albumin and sex hormone binding globulin, whereas ethinyl estradiol binds only to albumin (4). 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 (5).
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 ethinyl estradiol is believed to occur in gastrointestinal mucosa. Ethinyl estradiol may undergo enterohepatic circulation (6).
Excretion Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites (5, 6). Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately
0.4L/hr/kg) (1 to 3). Special Population Race: The effect of race on the disposition of Aurovela Fe 1.5/30 has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of Aurovela Fe 1.5/30 has not been evaluated.
In premenopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma ethinyl estradiol concentrations were higher and norethindrone concentrations were unchanged compared to concentrations in premenopausal women with normal renal function. Hepatic Insufficiency The effect of hepatic disease on the disposition of Aurovela Fe 1.5/30 has not been evaluated. However, ethinyl estradiol and norethindrone may be poorly metabolized in patients with impaired liver function.
Drug-Drug Interactions Numerous drug-drug interactions have been reported for oral contraceptives. A summary of these is found under PRECAUTIONS, Drug Interactions .
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Aurovela ® Fe 1.5/30 ( norethindrone acetate and ethinyl estradiol tablets, USP 1.5 mg/30 mcg and ferrous fumarate tablets, 75 mg) are white to off-white, round, flat-faced, beveled-edge, uncoated tablets, debossed with “S” on one side and “69” on other side of the tablet. Each brown mottled, round, flat-faced beveled-edge tablet contains 75 mg ferrous fumarate and is debossed with “S” on one side and “57” on other side of the tablet. 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.
1 Pouch of 28 tablets NDC 65862-941-87 Carton of 3 Pouches NDC 65862-941-88 Carton of 5 Pouches NDC 65862-941-58 Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Aurovela Fe 1.5/30 is progestogen-estrogen combination. Aurovela Fe 1.5/30: Each provides 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 white to off-white tablet contains norethindrone acetate USP (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol USP (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Each white to off-white tablet contains the following inactive ingredients: compressible sugar, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and vitamin E. The structural formulas are as follows: Each brown placebo tablet contains the following ingredients: croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Nat spearmint FL, povidone and sucralose.
The ferrous fumarate tablets do not serve any therapeutic purpose. Meets USP Dissolution Test 2. Chemical Structure1 Chemical Structure2
💬 Information for Patients ▾
PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( PATIENT PACKAGE INSERT BRIEF SUMMARY and DETAILED PATIENT PACKAGE INSERT ). Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs (see BOXED WARNING and CONTRAINDICATIONS ). Counsel patients that the increased risk of venous thromboembolism compared to non-users of CHCs is greatest after initially starting a CHC or restarting (following a 4-week or greater interruption in intake) the same or a different CHC (see WARNINGS ).
Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted infections. Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed (see DOSAGE AND ADMINISTRATION ).
Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs (see PRECAUTIONS ). Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established (see PRECAUTIONS ).
Counsel any patient who starts Aurovela Fe 1.5/30 postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a white to off-white tablet for 7 consecutive days (see DOSAGE AND ADMINISTRATION ). Counsel patients that amenorrhea may occur. Pregnancy should be considered in the event of amenorrhea, and should be ruled out if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness (see WARNINGS ).
Counsel patients with a history of depression that depression may reoccur. Women should contact their healthcare provider if depression occurs (see WARNINGS ).
⚠️ Precautions ▾
PRECAUTIONS 1. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections. 2.
Physical Examination and Follow-Up It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests.
In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3.
Lipid Disorders Women who are being treated for hyperlipidemia should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. 4.
Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function. 5.
Fluid Retention Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. 6.
Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. 7. Drug Interactions Effects of Other Drugs on Oral Contraceptives (69) Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin.
A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. Anticonvulsants : Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a reduction in contraceptive effectiveness. Troglitazone: Administration of troglitazone with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both by approximately 30%, which could result in a reduction in contraceptive effectiveness.
Antibiotics: Pregnancy while taking oral contraceptives has been reported when the oral contraceptives were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However, clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids. Atorvastatin: Coadministration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively.
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Co-administration of Aurovela Fe 1.5/30 with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations ( see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ). Co-administration of Aurovela Fe 1.5/30 and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations. Other: Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation.
A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding has been suggested with phenylbutazone. Effects of Oral Contraceptives on Other Drugs Oral contraceptive combinations containing ethinyl estradiol may inhibit the metabolism of other compounds. Increased… [Excerpted — this section continues on DailyMed.]
📚 References ▾
REFERENCES Back DJ, Breckenridge AM, Crawford FE, McIver M, Orme ML’E, Rowe PH and Smith E: Kinetics of norethindrone in women II. Single-dose kinetics. Clin Pharmacol Ther 1978; 24:448-453.
Hümpel M, Nieuweboer B, Wendt H and Speck U: Investigations of pharmacokinetics of ethinyloestradiol to specific consideration of a possible first-pass effect in women. Contraception 1979;19:421-432. Back DJ, Breckenridge AM, Crawford FE, MacIver M, Orme ML’E, Rowe PH and Watts MJ.
An investigation of the pharmacokinetics of ethynylestradiol in women using radioimmunoassay. Contraception 1979; 20:263-273. Hammond GL, Lähteenmäki PLA, Lähteenmäki P and Luukkainen T.
Distribution and percentages of non-protein bound contraceptive steroids in human serum. J Steriod Biochem 1982;17:375-380. Fotherby K.
Pharmacokinetics and metabolism of progestins in humans, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press, Ltd., New York, 1994; 99-126. Goldzieher JW. Pharmacokinetics and metabolism of ethynyl estrogens, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press Ltd., New York, 1994; 127-151.
Hatcher RA, et al. 1998. Contraceptive Technology, Seventeenth Edition.
New York: Irvington Publishers. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt.
1). New England Journal of Medicine , 305:612-618, 1981. Stadel, B.V.: Oral contraceptives and cardiovascular disease.
(Pt. 2). New England Journal of Medicine , 305:672-677, 1981.
Adam, S.A., and M. Thorogood: Oral contraception and myocardial infarction revisited: The effects of new preparations and prescribing patterns. Brit.
J. Obstet. and Gynec. , 88:838-845, 1981. Mann, J.I., and W.H.
Inman: Oral contraceptives and death from myocardial infarction. Brit. Med.
J. , 2(5965): 245-248, 1975. Mann, J.I., M.P. Vessey, M.
Thorogood, and R. Doll: Myocardial infarction in young women with special reference to oral contraceptive practice. Brit.
Med. J. , 2(5956):241-245, 1975. Royal College of General Practitioners' Oral Contraception Study: Further analyses of mortality in oral contraceptive users.
Lancet , 1:541-546, 1981. Slone, D., S. Shapiro, D.W.
Kaufman, L. Rosenberg, O.S. Miettinen, and P.D.
Stolley: Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives. N.E.J.M. , 305:420-424, 1981. Vessey, M.P.: Female hormones and vascular disease: An epidemiological overview.
Brit. J. Fam.
Plann. , 6:1-12, 1980. Russell-Briefel, R.G., T.M. Ezzati, R.
Fulwood, J.A. Perlman, and R.S. Murphy: Cardiovascular risk status and oral contraceptive use, United States, 1976-80.
Preventive Medicine , 15:352-362, 1986. Goldbaum, G.M., J.S. Kendrick, G.C.
Hogelin, and E.M. Gentry: The relative impact of smoking and oral contraceptive use on women in the United States. J.A.M.A. , 258:1339-1342, 1987.
Layde, P.M., and V. Beral: Further analyses of mortality in oral contraceptive users: Royal College General Practitioners' Oral Contraception Study. (Table 5) Lancet , 1:541-546, 1981.
Knopp, R.H.: Arteriosclerosis risk: The roles of oral contraceptives and postmenopausal estrogens. J. of Reprod. Med. , 31(9)(Supplement): 913-921, 1986.
Krauss, R.M., S. Roy, D.R. Mishell, J.
Casagrande, and M.C. Pike: Effects of two low-dose oral contraceptives on serum lipids and lipoproteins: Differential changes in high-density lipoproteins subclasses. Am.
J. Obstet. Gyn. , 145:446-452, 1983.
Wahl, P., C. Walden, R. Knopp, J.
Hoover, R. Wallace, G. Heiss, and B.
Rifkind: Effect of estrogen/progestin potency on lipid/lipoprotein cholesterol. N.E.J.M. , 308:862-867, 1983. Wynn, V., and R.
Niththyananthan: The effect of progestin in combined oral contraceptives on serum lipids with special reference to high-density lipoproteins. Am. J.
Obstet. and Gyn. , 142:766-771, 1982. Wynn, V., and I. Godsland: Effects of oral contraceptives on carbohydrate metabolism.
J. Reprod. Medicine , 31 (9)(Supplement): 892-897, 1986.
L… [Excerpted — this section continues on DailyMed.]
📄 Patient Package Insert ▾
BRIEF SUMMARY PATIENT PACKAGE INSERT This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted infections. Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.
This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. 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 about 1% per year when used without missing any pills.
The typical failure rate of large numbers of pill users is less than 3% per year 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. The risks associated with taking oral contraceptives increase significantly if you: Smoke Have high blood pressure, diabetes, high cholesterol Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast, jaundice, or malignant or benign liver tumors.
You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses.
These side effects, especially nausea, vomiting, and breakthrough bleeding 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 are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body.
As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer.
However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.
The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease oral contraceptive effectiveness.
There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. Some studies have found an increase in the risk of developing cancer of the cervix in women taking the pill, but this finding may be related to differences in sexual behavior or other factors not related to use of the pill. Taking the pill provides some important non-contraceptive benefits.
These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your healthcare provider. Y… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg/30 mcg and 75 mg Pouch Label NDC 65862-941-87 28 DAY REGIMEN Aurovela ® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and f errous fumarate tablets**) ** Ferrous fumarate tablets are not USP for dissolution and assay. THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
Rx only 28-TABLET POUCH AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg/30 mcg and 75 mg Pouch Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg/30 mcg and 75 mg Blister Carton NDC 65862-941-88 28 DAY REGIMEN Aurovela ® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and f errous fumarate tablets**) ** Ferrous fumarate tablets are not USP for dissolution and assay. THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
Rx only FIVE 28-TABLET POUCH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg/30 mcg and 75 mg Blister Carton
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