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NDC 75834-0129-29 Norethindrone Acetate and Ethinyl Estradiol .0025; .5 mg/1; mg/1 Details
Norethindrone Acetate and Ethinyl Estradiol .0025; .5 mg/1; mg/1
Norethindrone Acetate and Ethinyl Estradiol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is ETHINYL ESTRADIOL; NORETHINDRONE ACETATE.
MedlinePlus Drug Summary
Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases. Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne. Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.
Related Packages: 75834-0129-29Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Estrogen and Progestin (Oral Contraceptives)
Product Information
NDC | 75834-0129 |
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Product ID | 75834-129_4ffa902e-2cf8-4160-ba1e-f27e48b8e502 |
Associated GPIs | 24993002250305 |
GCN Sequence Number | 049858 |
GCN Sequence Number Description | norethindrone ac-eth estradiol TABLET 0.5MG-2.5 ORAL |
HIC3 | G1A |
HIC3 Description | ESTROGENIC AGENTS |
GCN | 15567 |
HICL Sequence Number | 001455 |
HICL Sequence Number Description | NORETHINDRONE ACETATE-ETHINYL ESTRADIOL |
Brand/Generic | Generic |
Proprietary Name | Norethindrone Acetate and Ethinyl Estradiol |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Norethindrone Acetate and Ethinyl Estradiol |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | .0025; .5 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
Labeler Name | Nivagen Pharmaceuticals, Inc. |
Pharmaceutical Class | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA203435 |
Listing Certified Through | 2024-12-31 |
Package
NDC 75834-0129-29 (75834012929)
NDC Package Code | 75834-129-29 |
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Billing NDC | 75834012929 |
Package | 3 BLISTER PACK in 1 CARTON (75834-129-29) / 28 TABLET in 1 BLISTER PACK (75834-129-84) |
Marketing Start Date | 2016-11-25 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 1.36807 |
Pricing Unit | EA |
Effective Date | 2022-11-23 |
NDC Description | NORETHIND-ETH ESTRAD 0.5-2.5 |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2022-11-23 |