Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53002-2616 | I | Inactivated by FDA | 2026-07-31 | ||
| excluded package | package | 53002-2616 | 53002-2616-1 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 53002-2616 | 53002-2616-3 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 53002-2616 | 53002-2616-6 | I | Inactivated by FDA | 2026-07-31 |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091454-001 | LARIN FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET / ORAL-28 | AB | 2013-08-26 |
| Application-product | TE code |
|---|---|
| A091454-001 | AB |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Larin Fe 1/20 | NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE | Northstar Rx LLC | e71741c8-10fa-4eee-b0da-e42af451222c | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | |
| Microgestin Fe 1/20 | NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE | Mayne Pharma Inc. | 5bf28e22-8f58-4166-8a62-2717ecd6a70f | 2025-08-04 | Warnings, Adverse reactions | |
| Microgestin Fe 1/20 | NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE | Dr. Reddy's Laboratories Inc. | 5e622180-cbb0-4466-a810-98b3b9663b59 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including LARIN™ Fe 1/20, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. Oral contraceptives, also known as "birth control pills" or "the pill," are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: Smoke Have high blood pressure, diabetes, high cholesterol Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast, jaundice, or malignant or benign liver tumors. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from References 8 and 9 with the author's permission). For further information, the reader is referred to a text on epidemiological methods. 1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial i nfarction An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six (10-16). The risk is very low under the age of 30. Smoking in combination with oral contraceptive use has been shown to contribute s...
TABLE III: ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN BY FERTILITY CONTROL METHOD ACCORDING TO AGEMethod of control and outcome15 -1920 -2425 -2930 -3435 -3940 -44No fertility control methods7.07.49.114.825.728.2Oral contraceptives non-smoker**0.30.50.91.913.831.6Oral contraceptives smoker**2.23.46.613.551.1117.2IUD**0.80.81.01.01.41.4Condom*1.11.60.70.20.30.4Diaphragm/spermicide*1.91.21.21.32.22.8Periodic abstinence*2.51.61.61.72.93.6*Deaths are birth related.**Deaths are method related.Adapted from H.W. Ory, Reference 41.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section) : Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1) (70-74). Three studies compared breast cancer risk between current or recent COC users (
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-2616-1 | Microgestin Fe 1/20 | 1 in 1 CARTON | KIT | 1 | 3 | |
| 53002-2616-1 | Microgestin Fe 1/20 | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 53002-2616-3 | Microgestin Fe 1/20 | 3 in 1 CARTON | KIT | 3 | 3 | |
| 53002-2616-3 | Microgestin Fe 1/20 | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 53002-2616-6 | Microgestin Fe 1/20 | 6 in 1 CARTON | KIT | 6 | 3 | |
| 53002-2616-6 | Microgestin Fe 1/20 | 1 in 1 BLISTER PACK | KIT | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-2616 | MICROGESTIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 6 package rows | 20220421_9bff0c82-55b0-4eea-9c91-534341be0a05.zip |
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1358775 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Microgestin Fe 1/20 28 Day] | BPCK | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358763 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358763 | Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358775 | MICROGESTIN Fe 1/20 28 Day Pack | PSN | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358762 | norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358762 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet | SCD | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358762 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet | SY | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| 1358775 | Microgestin Fe 1/20 28 Day Pack | SY | 9bff0c82-55b0-4eea-9c91-534341be0a05 | 3 |
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-2616-1 | 53002261601 | 1 BLISTER PACK in 1 CARTON (53002-2616-1) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 53002-2616-3 | 53002261603 | 3 BLISTER PACK in 1 CARTON (53002-2616-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 53002-2616-6 | 53002261606 | 6 BLISTER PACK in 1 CARTON (53002-2616-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |