Home › NDC Lookup › Ingredients › Norethindrone Acetate › 70700-0326-50
Gallifrey Norethindrone Acetate 5 mg Tablet, 50-count — NDC 70700-0326-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gallifrey Norethindrone Acetate 5 mg Tablet, 50-count — NDC 70700-326-50 (Billing 70700-0326-50)

by Xiromed LLC · 50 TABLET in 1 BOTTLE

This is a package of 50 tablets of Gallifrey Norethindrone Acetate 5 mg Tablet from Xiromed LLC, marketed since Sep 2024 and currently FDA-listed; retail pharmacies pay about $0.2898 per tablet (NADAC). It is this product's only package size.

NDC 70700-0326-50
🏷️ FDA NDC (as labeled) 70700-326-50 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 70700-326-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70700 labeler · 326 product · 50 package
Package marketed since
Sep 6, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
50 EA per package
Barcode (UPC-A, from the NDC)
3 7070032650 3
Medicaid fills, this package
47,174 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70700-326-50
Product NDC 70700-326
11-digit billing NDC 70700032650
NCPDP billing unit EA — each (per item)
RxCUI 1000405, 2696255
UNII 9S44LIC7OJ
Application # ANDA205278
SPL Set ID 26130af6-221b-2349-81b6-0c0132d6e524
Established class (EPC) Progestin
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-06
Route ORAL
Dosage form TABLET
Substance NORETHINDRONE ACETATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 26000030100305
GCN Seq No 003274
GCN 11280
HICL code 001443
Ingredient (HICL) Norethindrone Acetate
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G2
Therapeutic class — intermediate (HIC2) Progestogens
HIC3 code G2A
Therapeutic class — specific (HIC3) Progestational Agents
AHFS code 68:32.00.00
AHFS class Progestins
FDB label name GALLIFREY 5 MG TABLET
FDB brand name Gallifrey
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003274
  • GCN: 11280
  • GPI-14 (Medi-Span): 26000030100305
  • HICL (First Databank): 001443
  • AHFS class code: 68:32.00.00
  • RxCUI (RxNorm): 1000405
Why two NDCs? The FDA registers this code as 70700-326-50 — 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 → 70700-0326-50. 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 Progestin class.

Pharmacologic class Progestin
Drug family (ATC) Progestogens and estrogens, sequential preparations, Progestogens, Estren derivatives
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.

Clinical

Label name GALLIFREY 5 MG TABLET Ingredient Norethindrone Acetate
📗 Our plain-language guide HelloPharmacist
  • Most norethindrone products, like Errin, Camila and Emzahh, are progestin-only birth control pills that prevent pregnancy. Norethindrone acetate tablets, such as Gallifrey, are use...
  • Take one tablet by mouth every day at the same time. Don't take a break between packs. Following the schedule exactly gives you the best protection, so follow your label and the pa...
  • Changes in your bleeding are the most common, including irregular or frequent bleeding. Some people get headache, breast tenderness, nausea or dizziness. Call me or your doctor if...
  • It's best not to. Smoking greatly raises the risk of heart attack and stroke in women using oral contraceptives. If you smoke, let's talk about options and quitting.
📖 Read our full Norethindrone guide →
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.

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 $0.290 $14.49 / 50 tablets
Medicaid paysCMS SDUD · 12 mo $0.4538 $22.69 / 50 tablets
Medicare drug plans payPart D · Q2 2026 $0.4645 $23.23 / 50 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.302 $0.290
▼ Down 4% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70700-0326-50 You're viewing this Main listing 50 TABLET in 1 BOTTLE 2024-09-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Norethindrone Acetate 5 mg 00555-0211-10 Teva 50 tablets $0.290 AB Availability likely —
Norethindrone acetate 5 mg 50742-0267-50 Ingenus 50 tablets $0.290 AB Availability likely —
Norethindrone Acetate 5 mg 60687-0921-21 American 30 tablets $0.290 AB Availability likely —
Gallifrey 5 mgthis 70700-0326-50 Xiromed 50 tablets $0.290 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 —
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
Sep 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.

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.

🧪 Avoiding an ingredient? See Norethindrone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    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.
  • 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.
  • 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.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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.

Manufacturer & labeler

LabelerXiromed LLC
Application holderXIROMED LLC
FDA applicationANDA205278 (ANDA)
Labeler code70700
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio39 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 61 words ▾

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 162 words ▾

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 75 words ▾

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 82 words ▾

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 109 words ▾

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 18 words ▾

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

🧬 Clinical Pharmacology ~2 min read ▾

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 70 words ▾

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 60 words ▾

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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS 1. General Precautions Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, require careful observation In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism.

The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy The pathologist should be advised of progestin therapy when relevant specimens are submitted 2. Information for the Patient Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe norethindrone acetate tablets.

3. Drug/Laboratory Tests Interactions The following laboratory test results may be altered by the use of estrogen/progestin combination drugs: 1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor X a and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.

2. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radio immunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG.

Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. 3.

Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased circulating corticosteroid and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1- antitrypsin, ceruloplasmin).

4. Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. 5.

Impaired glucose metabolism. 6. Reduced response to metyrapone test.

4. Carcinogenesis, Mutagenesis, and Impairment of Fertility Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted.

There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established. 5.

Pregnancy Category X Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses.

6. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman.

7. Pediatric Use Norethi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

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.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Gallifrey TM (Norethindrone Acetate Tablets, USP), 5 mg Read this PATIENT INFORMATION before you start taking Gallifrey and read what you get each time you refill Gallifrey. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition.

What is the most important information I should know about Gallifrey (A Progestin Hormone)? Do not use Gallifrey if you are pregnant, breast-feeding or are trying to conceive. Do not use Gallifrey if you have had a previous blood clot, stroke, or heart attack.

Do not use Gallifrey if you are postmenopausal. What is Gallifrey? Gallifrey is similar to the progesterone hormones naturally produced by the body.

Your healthcare provider may provide Gallifrey as individual tablets. What is Gallifrey used for? Gallifrey is used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance.

Who should not take Gallifrey? You should not take Gallifrey if you are postmenopausal, pregnant or breast-feeding. You should not take Gallifrey if you have the following conditions: Known or suspected pregnancy .

Gallifrey is not indicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take Gallifrey during the first 4 months of pregnancy (mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus). If you take Gallifrey and later find out you were pregnant, talk with your healthcare provider right away History of blood clots in the legs, lungs, eyes, brain, or elsewhere, or a past history of these conditions Liver impairment or disease Known or suspected cancer of the breast.

If you have or had cancer of the breast, talk with your healthcare provider about whether you should take Gallifrey. Undiagnosed vaginal bleeding Hypersensitivity to Gallifrey . See the end of this leaflet for a list of all of the ingredients in Gallifrey.

What are the risks associated with Gallifrey? Risk to the Fetus: Gallifrey should not be used if you are pregnant. Gallifrey is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women.

There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.

You should avoid using Gallifrey during pregnancy. If you take Gallifrey and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible. Abnormal Blood Clotting: Use of progestational drugs, such as Gallifrey, has been associated with changes in the blood-clotting system.

These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems.

Any of these conditions may cause death or serious long-term disability. Call your healthcare provider right away if you suspect you have any of these conditions. He or she may advise you to stop using the drug.

Eye A… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 23 words ▾

PRINCIPAL DISPLAY PANEL – 5 mg NDC 70700-326-50 Gallifrey (Norethindrone Acetate Tablets, USP, 5 mg) Rx only 50 Tablets 5 mg Bottle Label

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

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 this package alone, 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 – Q1 2026 · 5 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
47.2K
Units reimbursed last 4 qtrs
2.6M
Gross reimbursed last 4 qtrs
$1.19M
Avg / prescription
$25.23
Avg / unit
$0.4538
Latest quarter Q1 2026
12.5KRx
Medicaid pays / ea
$0.4538
gross reimbursed
vs
NADAC / ea
$0.2898
acquisition cost
=
Spread
+$0.1640
+57% 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 ⓘ
43% FFS 57% MCO
Fee-for-service · 20,064 Rx Managed care · 27,110 Rx
State Medicaid map
Alaska: no data reported AK Maine: 35,205 units · 2,524 per 100k residents ME Washington: 40,175 units · 514 per 100k residents WA Idaho: 8,841 units · 450 per 100k residents ID Montana: 4,422 units · 391 per 100k residents MT North Dakota: 2,388 units · 305 per 100k residents ND Minnesota: 86,667 units · 1,511 per 100k residents MN Wisconsin: 104,516 units · 1,768 per 100k residents WI Michigan: 147,047 units · 1,465 per 100k residents MI New York: 195,651 units · 1,000 per 100k residents NY Vermont: 58,130 units · 8,985 per 100k residents VT New Hampshire: 1,878 units · 134 per 100k residents NH Oregon: 56,549 units · 1,336 per 100k residents OR Nevada: 14,056 units · 440 per 100k residents NV Wyoming: 572 units · 97.9 per 100k residents WY South Dakota: 2,835 units · 308 per 100k residents SD Iowa: 36,664 units · 1,143 per 100k residents IA Illinois: 33,896 units · 270 per 100k residents IL Indiana: 19,924 units · 290 per 100k residents IN Ohio: 121,326 units · 1,029 per 100k residents OH Pennsylvania: 72,133 units · 557 per 100k residents PA New Jersey: 36,406 units · 392 per 100k residents NJ Massachusetts: 4,176 units · 59.6 per 100k residents MA California: 304,512 units · 782 per 100k residents CA Utah: 18,053 units · 528 per 100k residents UT Colorado: 137,243 units · 2,335 per 100k residents CO Nebraska: 11,896 units · 601 per 100k residents NE Missouri: 72,324 units · 1,167 per 100k residents MO Kentucky: 76,929 units · 1,700 per 100k residents KY West Virginia: 39,243 units · 2,217 per 100k residents WV Virginia: 30,875 units · 354 per 100k residents VA Maryland: 58,445 units · 946 per 100k residents MD Connecticut: 58,835 units · 1,627 per 100k residents CT Rhode Island: 16,189 units · 1,478 per 100k residents RI Arizona: 64,884 units · 873 per 100k residents AZ New Mexico: 70,515 units · 3,336 per 100k residents NM Kansas: 10,805 units · 368 per 100k residents KS Arkansas: 33,904 units · 1,105 per 100k residents AR Tennessee: 26,455 units · 371 per 100k residents TN North Carolina: 199,890 units · 1,845 per 100k residents NC South Carolina: 16,431 units · 306 per 100k residents SC Delaware: 46,129 units · 4,474 per 100k residents DE Oklahoma: 48,772 units · 1,203 per 100k residents OK Louisiana: 55,076 units · 1,204 per 100k residents LA Mississippi: no data reported MS Alabama: 28,145 units · 551 per 100k residents AL Georgia: 4,807 units · 43.6 per 100k residents GA D.C.: 305 units · 44.9 per 100k residents DC Hawaii: 2,029 units · 141 per 100k residents HI Texas: 100,975 units · 331 per 100k residents TX Florida: 5,196 units · 23.0 per 100k residents FL
Units reimbursed · per 100k residents
23.08,985
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 Vermont 8,985 /100k
2 Delaware 4,474 /100k
3 New Mexico 3,336 /100k
4 Maine 2,524 /100k
5 Colorado 2,335 /100k
6 West Virginia 2,217 /100k
7 North Carolina 1,845 /100k
8 Wisconsin 1,768 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gallifrey — 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 Gallifrey. 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
$120K
Claims incl. refills
3.2K
Beneficiaries
2.4K
Spend / beneficiary
$49.63
Spend / claim
$37.97
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Norethindrone Acetate — the ingredient across all brands.

Top reported reactions

Nausea905
Headache816
Fatigue658
Pain537
Therapy Interrupted512
Anxiety485
Dizziness464

Reporter sex

0 reports

Serious outcomes

Disabling289
Life-threatening251
Death104
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,323 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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.