DEBLITANE Norethindrone Kit
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Progestin class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Norethindrone is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Norethindrone is also used to treat abnormal periods or bleeding and to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 3 months and who are not pregnant or experiencing menopause (change of life; the end of monthly menstrual periods). Norethindrone is in a class of medications called progestins. It...
Read the full MedlinePlus article ↗- It depends on the product. Most norethindrone tablets — including brands like Camila, Errin, Emzahh, and Affodel — are progestin-only birth control pills taken daily to prevent pre...
- Regular combination birth control pills contain two hormones — estrogen and progestin. Norethindrone is a progestin-only pill, sometimes called the 'mini-pill.' Because it has no e...
- How is this different from regular birth control pills?
- The most common thing people notice is irregular bleeding — spotting between periods, or changes in your cycle. Headache, breast tenderness, nausea, and dizziness are also reported...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Norethindrone — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.091 | $0.54 / 6 kit |
| Medicaid paysCMS SDUD · 12 mo | $0.2221 | $1.33 / 6 kit |
| Medicare drug plans payPart D · Q2 2026 | $0.1328 | $0.80 / 6 kit |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sharobel 16714-0441-01 | Northstar | 1 packet | $0.091 | AB2 | Availability likely | — |
| Deblitanethis 16714-0440-04 | Northstar | 1 kit | $0.091 | AB1 | Availability likely | — |
Where does this data come from?
⏳ 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 16714-0440-01 | 1 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK | $0.0907 / ea | $0.09 | 2013-09-13 | Active |
| 16714-0440-02 | 1 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK | — | — | 2020-01-01 | Active |
| 16714-0440-03 | 3 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK | — | — | 2020-01-01 | Active |
| 16714-0440-04 You're viewing this | 6 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK | $0.0907 / ea | $0.54 | 2013-09-13 | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0907 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 99% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 16714-0440-04?
What NDC number is used to bill for this package of DEBLITANE Norethindrone 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.
🧭 About this NDC listing & data coverage
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 |
Questions about this listing
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, DEBLITANE TM must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.
⛔ Contraindications ▾
CONTRAINDICATIONS Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease
⚠️ Warnings ▾
WARNINGS Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. DEBLITANE TM does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives.
The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.
The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. Ectopic Pregnancy The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years.
Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.
2. Delayed follicular atresia/Ovarian cysts If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously.
Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention. 3.
Irregular genital bleeding Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.
4. Carcinoma of the breast and reproductive organs Some epidemiologic studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increase the risk.
Women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia. 5. Hepatic Neoplasia Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States.
Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage. Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare.
There is insufficient data to determine whether POPs increase the risk of developing h…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.
🆘 Overdosage ▾
OVERDOSAGE There have been no reports of serious ill effects from overdosage, including ingestion by children.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 1. Mode of Action DEBLITANE TM progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. 2.
Pharmacokinetics Absorption: Norethindrone is rapidly absorbed with maximum plasma concentrations occurring within 1 to 2 hours after DEBLITANE TM administration (see Table 1). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first pass metabolism resulting in an absolute bioavailability of approximately 65%. Peak plasma concentrations occur approximately 1 hour after administration (mean T max 1.2 hours).
The mean (SD) C max was 4816.8 (1532.6) pg/mL and generally occurred within 1 hour (mean) of tablet administration, ranging from 0.5 to 2 hours. The mean (SD) C avg was 885 (250) pg/mL, however, the mean concentration at 24 hrs was 130 (47) pg/mL. Table 1 provides summary statistics of the pharmacokinetic parameters associated with single dose Norethindrone Tablets administration.
The food effect on the rate and extent of norethindrone absorption after DEBLITANE TM administration has not been evaluated. Distribution: Following oral administration, norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is approximately 4 L/kg.
Metabolism: Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5% of a norethindrone dose is excreted unchanged; greater than 50% and 20 to 40% of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfate, with glucuronides accounting for most of the urinary metabolites. Excretion: Plasma clearance rate for norethindrone has been estimated to be approximately 600 L/day.
Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following single dose administration of Norethindrone Tablet is approximately 8 hours. Figure 1
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED DEBLITANE TM (Norethindrone Tablets, USP) contain 28 round yellow tablets in a blister card (NDC 16714-440-01). Each yellow tablet, debossed with “K2” on one side, contains 0.35 mg norethindrone. DEBLITANE TM tablets are available in the following configurations: Carton of 1 NDC 16714-440-02 Carton of 3 NDC 16714-440-03 Carton of 6 NDC 16714-440-04 STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Each yellow DEBLITANE TM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No.
2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one. The structural formula follows: Therapeutic class = Oral Contraceptive Norethindrone Structure