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NDC 00378-7291-89 Norethindrone Acetate 5 mg/1 Details
Norethindrone Acetate 5 mg/1
Norethindrone Acetate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is NORETHINDRONE ACETATE.
MedlinePlus Drug Summary
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 works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones. Norethindrone is also used to prevent pregnancy. Norethindrone is sold under different brand names and is taken in smaller amounts when it used to prevent pregnancy. This monograph does not include information on the use of norethindrone to prevent pregnancy. If you are taking norethindrone to prevent pregnancy, read the monograph entitled Progestin-Only (norethindrone) Oral Contraceptives.
Related Packages: 00378-7291-89Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Norethindrone
Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Progestin-only (norethindrone) oral contraceptives are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.
Related Packages: 00378-7291-89Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Progestin-Only (norethindrone) Oral Contraceptives
Product Information
| NDC | 00378-7291 |
|---|---|
| Product ID | 0378-7291_f6ab678f-03e6-43a2-a20a-e22a6fd485c1 |
| Associated GPIs | 26000030100305 |
| GCN Sequence Number | 003274 |
| GCN Sequence Number Description | norethindrone acetate TABLET 5 MG ORAL |
| HIC3 | G2A |
| HIC3 Description | PROGESTATIONAL AGENTS |
| GCN | 11280 |
| HICL Sequence Number | 001443 |
| HICL Sequence Number Description | NORETHINDRONE ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Norethindrone Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Norethindrone Acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | NORETHINDRONE ACETATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Progesterone Congeners [CS], Progestin [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205278 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-7291-89 (00378729189)
| NDC Package Code | 0378-7291-89 |
|---|---|
| Billing NDC | 00378729189 |
| Package | 50 TABLET in 1 BOTTLE (0378-7291-89) |
| Marketing Start Date | 2019-07-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.31085 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | NORETHINDRONE 5 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |