| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076381-001 | JUNEL 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2003-05-30 |
| Application-product | TE code |
|---|---|
| A076381-001 | 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 |
|---|---|---|---|---|---|---|
| Loestrin Fe 28 Day | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | Teva Women's Health LLC | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 2025-02-20 | 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 Loestrin, 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.
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 infarction 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 su...
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 to 1920 to 2425 to 2930 to 3435 to 3940 to 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 (
| Ingredient | Strength |
|---|---|
| NORETHINDRONE ACETATE | 30 ug/1 |
| ETHINYL ESTRADIOL | 1.5 mg/1 |
| Field | Values |
|---|---|
| Unii | 9S44LIC7OJ, 423D2T571U |
| Rxcui | 259176, 1358762, 1358763, 1358770, 1358776, 1358781, 1359022, 1359023, 1359026, 1359028, 1359031 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51285-127-97 | Loestrin21 Day | 1 in 1 POUCH | TABLET | 1 | 12 | |
| 51285-127-97 | Loestrin21 Day | 5 in 1 CARTON | TABLET | 5 | 12 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51285-127-97 | EA - Each | 51285-127 | 5b4e9209-372c-4cef-8e28-07eb21dedcb0 | 1 | 2015-03-03 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51285-127 | LOESTRIN 21 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET LOESTRIN FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250416_f29ebcb5-7e65-4092-bfaa-f5ec026fc255.zip |
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1358781 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) } Pack [Loestrin 1/20 21 Day] | BPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358770 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Loestrin Fe 1/20 28 Day] | BPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359031 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack [Loestrin 1.5/30 21 Day] | BPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359026 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Loestrin Fe 1.5/30 28 Day] | BPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358776 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) } Pack | GPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358763 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359028 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack | GPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359023 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358776 | Eth estra-Noreth Ac 0.02-1 MG (21) Oral Tablet 21 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359023 | Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359028 | Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358763 | Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359031 | LOESTRIN 1.5/30 21 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358781 | LOESTRIN 1/20 21 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359026 | LOESTRIN Fe 1.5/30 28 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358770 | LOESTRIN Fe 1/20 28 Day Pack | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358762 | norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359022 | norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet | PSN | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358762 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet | SCD | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359022 | ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet | SCD | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358762 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet | SY | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359022 | ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet | SY | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359031 | Loestrin 1.5/30 21 Day Pack | SY | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358781 | Loestrin 1/20 21 Day Pack | SY | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1359026 | Loestrin Fe 1.5/30 28 Day Pack | SY | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| 1358770 | Loestrin Fe 1/20 28 Day Pack | SY | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 12 |
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51285-127-97 | 51285012797 | 5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 5 pouch | 2015-02-26 | 0000-00-00 | No | No | Current |