| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091234-001 | DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET / ORAL-28 | AB | 2013-07-12 |
| Application-product | TE code |
|---|---|
| A091234-001 | 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 |
|---|---|---|---|---|---|---|
| Juleber | DESOGESTREL AND ETHINYL ESTRADIOL | Northstar Rx LLC | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 2025-11-18 | Boxed warning, Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including JULEBER™, should not be used by women who are over 35 years of age and smoke.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including JULEBER TM , should not be used by women who are over 35 years of age and smoke. 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 formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses 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 refs. 2 and 3 with the authors’ permission). For further information, the reader is referred to a text on epidemiological methods. 1. THROMBOEMBOLIC DISORDER AND OTHER VASCULAR PROBLEMS a. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case cont...
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including JULEBERTM, should not be used by women who are over 35 years of age and smoke.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC. at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 2). Three studies compared breast cancer risk between current or recent COC users (
| Field | Values |
|---|---|
| Rxcui | 240707, 748797, 749848, 1605086 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-464-01 | Juleber | 1 in 1 BLISTER PACK | KIT | 1 | 11 | |
| 16714-464-01 | Juleber | 1 in 1 PACKET | KIT | 1 | 11 | |
| 16714-464-02 | Juleber | 1 in 1 CARTON | KIT | 1 | 11 | |
| 16714-464-02 | Juleber | 1 in 1 BLISTER PACK | KIT | 1 | 11 | |
| 16714-464-03 | Juleber | 3 in 1 CARTON | KIT | 3 | 11 | |
| 16714-464-03 | Juleber | 1 in 1 BLISTER PACK | KIT | 1 | 11 | |
| 16714-464-04 | Juleber | 1 in 1 BLISTER PACK | KIT | 1 | 11 | |
| 16714-464-04 | Juleber | 6 in 1 CARTON | KIT | 6 | 11 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-464-01 | EA - Each | 16714-464 | 88f51ddc-8d31-4572-ae8d-38fbc26db38f | 1 | 2016-02-04 |
| 16714-464-04 | EA - Each | 16714-464 | b633af7e-ee48-48d7-8839-8867ca215439 | 1 | 2015-11-12 |
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1605086 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Juleber 28 Day] | BPCK | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 749848 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 749848 | Desogest-Eth estra 0.15-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 240707 | desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 748797 | inert 1 MG Oral Tablet | PSN | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 1605086 | Juleber 28 Day Pack | PSN | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 240707 | desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | SCD | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| 1605086 | Juleber 28 Day Pack | SY | de9a2d1b-15f6-453f-b36b-1c2a43c4918d | 11 |
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-464-01 | 16714046401 | 1 BLISTER PACK in 1 PACKET (16714-464-01) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2013-07-12 | 0000-00-00 | No | No | Current |
| 16714-464-02 | 16714046402 | 1 BLISTER PACK in 1 CARTON (16714-464-02) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2013-07-12 | 0000-00-00 | No | No | Current |
| 16714-464-03 | 16714046403 | 3 BLISTER PACK in 1 CARTON (16714-464-03) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2013-07-12 | 0000-00-00 | No | No | Current |
| 16714-464-04 | 16714046404 | 6 BLISTER PACK in 1 CARTON (16714-464-04) / 1 KIT in 1 BLISTER PACK | 6 blister pack | 2013-07-12 | 0000-00-00 | No | No | Current |