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Gallifrey

Generic: Norethindrone Acetate

Verified·Apr 23, 2026
Manufacturer
Invalid Entry
NDC
70700-326
RxCUI
1000405
Route
ORAL
ICD-10 indication
N91.1

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About Gallifrey

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Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Gallifrey. Official source: DailyMed (NLM) · Label effective Aug 31, 2024

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.
Drug interactions
Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate tablets have been conducted.
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)

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How Gallifrey appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

54%

2,990 of 5,509 plans

Most common tier

Tier 2

On 53% of covering formularies

Prior authorization required

0%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)63
21%
Tier 2 (generic)158
53%
Tier 3 (preferred brand)76
25%
Tier 4 (non-preferred brand)3
1%

Step therapy: 0% of formularies

Quantity limits: 0% of formularies

Coverage breadth: 300 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.