Drug Catalog - Product Detail
NORETHINDRONE ACETATE/ETHINYL ESTRADIOL 0.5MG/2.5MCG TAB 3X28
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 75834-0129-29 | NIVAGEN PHARMACEUTICALS | 28 | 0.5-2.5MG-MCG | TABLET |
PACKAGE FILES
Generic Name
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Substance Name
ETHINYL ESTRADIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203435
Description
11 DESCRIPTION Norethindrone acetate and ethinyl estradiol tablets are a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following two strengths of norethindrone acetate and ethinyl estradiol tablets are available: 0.5 mg/2.5 mcg: Each round light yellow tablet contains 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol; debossed with N1 on one side. 1 mg/5 mcg: Each round white tablet contains 1 mg norethindrone acetate and 5 mcg ethinyl estradiol; debossed with N2 on one side. Each white tablet also contains lactose monohydrate, pregelatinized starch, polyethylene glycol, magnesium stearate, ethyl cellulose, vitamin E, titanium dioxide, hypromelloses, macrogol/PEG, triacetin, polydextrose. Each light yellow tablet also contains lactose monohydrate, pregelatinized starch, polyethylene glycol, magnesium stearate, ethyl cellulose, vitamin E, iron oxide yellow, iron oxide black, talc, polyvinyl alcohol, titanium dioxide, lecithin (soya). The structural formulas are as follows. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]; Molecular Weight: 340.47 Molecular Formula: C22H28O3 Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]; Molecular Weight: 296.41 Molecular Formula: C20H24O2 Chemical Structure Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Norethindrone acetate and ethinyl estradiol tablets are available in the following strength and package sizes: 1. 75834-129-84 Blister card of 28 round light yellow tablets with 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol 2. 75834-129-29 Carton containing 3 × 28 tablet blister cards each in a plastic compact. Each blister card contains 28 round light yellow tablets with 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol 3. 75834-129-90 Bottle of 90 round light yellow tablets with 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol 4. 75834-130-84 Blister card of 28 round white tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol 5. 75834-130-29 Carton containing 3 × 28 tablet blister cards each in a plastic compact. Each blister card contains 28 round white tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol 6. 75834-130-90 Bottle of 90 round white tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol. 16.2 Storage and Handling Store at 20º-25º C (68º-77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Norethindrone acetate and Ethinyl estradiol tablets are an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be condisered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. One tablet taken orally once daily ( 2.1 , 2.2 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Norethindrone acetate and ethinyl estradiol tablets therapy consists of a single tablet to be taken orally once daily. 2.2 Prevention of Postmenopausal Osteoporosis Norethindrone acetate and ethinyl estradiol tablets therapy consists of a single tablet taken orally once daily.