Gallifrey Norethindrone Acetate 5 mg Tablet, 50-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progestin class.
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🏭 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...
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💊 What it looks like
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🧪 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.
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Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.295 | $14.74 / 50 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4876 | $24.38 / 50 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.4645 | $23.23 / 50 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Norethindrone Acetate 5 mg 00555-0211-10 | Teva | 50 tablets | $0.295 | AB | Availability likely | — |
| Norethindrone acetate 5 mg 50742-0267-50 | Ingenus | 50 tablets | $0.295 | AB | Availability likely | — |
| Norethindrone Acetate 5 mg 60687-0921-21 | American | 30 tablets | $0.295 | AB | Availability likely | — |
| Gallifrey 5 mgthis 70700-0326-50 | Xiromed | 50 tablets | $0.295 | AB | Availability likely | — |
| Norethindrone Acetate 5 mg 42291-0650-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Norethindrone Acetate 5 mg 51407-0599-50 | Golden | 50 tablets | — | AB | FDA listed | — |
| Norethindrone Acetate 5 mg 65162-0475-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Norethindrone Acetate 5 mg 68462-0304-05 | Glenmark | 500 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70700-0326-50 You're viewing this | 50 TABLET in 1 BOTTLE (70700-326-50) | 2024-09-06 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Therapy with Gallifrey tablets must be adapted to the specific indications and therapeutic response of the individual patient. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 mg to 10 mg Gallifrey may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Gallifrey therapy.
Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Gallifrey. Endometriosis: Initial daily dosage of 5 mg Gallifrey for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Gallifrey is reached.
Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
⛔ Contraindications ▾
CONTRAINDICATIONS Known or suspected pregnancy. There is no indication for norethindrone acetate tablets in pregnancy. (See PRECAUTIONS .) Undiagnosed vaginal bleeding Known, suspected or history of cancer of the breast Active deep vein thrombosis, pulmonary embolism or history of these conditions Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) Impaired liver function or liver disease As a diagnostic test for pregnancy Hypersensitivity to any of the drug components
⚠️ Warnings ▾
WARNINGS 1. Cardiovascular disorders Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. 2.
Visual abnormalities Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS See WARNINGS and PRECAUTIONS . The following adverse reactions have been observed in women taking progestins: Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Edema Changes in weight (decreases, increases) Changes in the cervical squamo-columnar junction and cervical secretions Cholestatic jaundice Rash (allergic) with and without pruritus Melasma or chloasma Clinical depression Acne Breast enlargement/tenderness Headache/migraine Urticaria Abnormalities of liver tests (i.e., AST, ALT, Bilirubin) Decreased HDL cholesterol and increased LDL/HDL ratio Mood swings Nausea Insomnia Anaphylactic/anaphylactoid reactions Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism) Optic neuritis (which may lead to partial or complete loss of vision)
🔄 Drug Interactions ▾
Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate tablets have been conducted.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone. PHARMACOKINETICS Absorption Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone.
Norethindrone acetate is rapidly absorbed from norethindrone acetate tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of norethindrone acetate tablets in 29 healthy female volunteers are summarized in Table 1. Table 1 Pharmacokinetic Parameters after a Single Dose of Norethindrone Acetate Tablets in Healthy Women AUC = area under the curve, C max = maximum plasma concentration, t max = time at maximum plasma concentration, t 1/2 = half-life, SD = standard deviation Norethindrone acetate tablets (n=29) Arithmetic Mean ± SD Norethindrone (NET) AUC (0-inf)(ng/ml*h) 166.9 ±
56.28C max (ng/ml) 26.19 ± 6.19 t max (h) 1.83 ± 0.58 t 1/2 (h) 8.51 ±
2.19Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions Effect of Food The effect of food administration on the pharmacokinetics of norethindrone acetate tablets has not been studied.
Distribution Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is about 4 L/kg. 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. Excretion Plasma clearance value for norethindrone is approximately
0.4L/hr/kg. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following a single dose administration of norethindrone acetate tablets is approximately 9 hours.
SPECIAL POPULATIONS Geriatrics The effect of age on the pharmacokinetics of norethindrone after norethindrone acetate tablets administration has not been evaluated. Race The effect of race on the disposition of norethindrone after norethindrone acetate tablets administration has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of norethindrone after norethindrone acetate tablets administration 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 norethindrone concentration was unchanged compared to concentrations in premenopausal women with normal renal function. Hepatic Insufficiency The effect of hepatic disease on the disposition of norethindrone after norethindrone acetate tablets administration has not been evaluated. However, norethindrone acetate tablets are contraindicated in markedly impaired liver function or liver disease.
Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate tablets have been conducted.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Gallifrey (Norethindrone acetate tablets, USP) is available as: 5 mg: White to off white, oval, flat-faced, beveled edge tablet debossed with 257 on one side of the tablet and a score (functional scoring) on the other side. Available as follows: Bottle of 50 tablets NDC 70700-326-50 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
📋 Description ▾
DESCRIPTION Gallifrey (Norethindrone acetate tablets, USP), 5 mg oral tablets. Gallifrey, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.
Gallifrey tablets contain the following inactive ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The USP Dissolution Test is pending. Norethindrone Acetate Structural Formula