Prescription drug · ANDA
Junel FE NDC 72189-215
Ethinyl estradiol 20 ug/1; Norethindrone acetate 1 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-215-28 | 72189021528 | 28 TABLET in 1 POUCH (72189-215-28)Marketed from Oct 6, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Junel FE
- Generic name (nonproprietary)
- junel fe
- Active ingredients
- Ethinyl estradiol — 20 ug/1Norethindrone acetate — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076380
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 72189-215_4d3a9c67-ae9a-d4c1-e063-6394a90aff1fSPL ID 4d3a9c67-ae9a-d4c1-e063-6394a90aff1fSPL set ID ea62a66e-d45d-11be-e053-2a95a90a7801RxCUI 1358762UNII 423D2T571U, 9S44LIC7OJ
- Pharmacologic class
- Estrogen; Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472189021528followed by a unit qualifier and the quantityPackage 72189-0215-28. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Junel21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076380
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Junel 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-9025 |
| Junel 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 | TabletOral | Proficient Rx LP | 82804-172 |
| Loestrin 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 | TabletOral | Teva Women's Health LLC | 51285-131 |