Prescription drug · ANDA
Junel Fe 28 Day NDC 50090-3122
norethindrone acetate and ethinyl estradiol and ferrous fumarate · Kit · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3122-0 | 50090312200 | 6 POUCH in 1 CARTON (50090-3122-0) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Aug 15, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 28 Day
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076064
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-3122_a0837632-a29a-4588-8979-73aa52d27193SPL ID a0837632-a29a-4588-8979-73aa52d27193SPL set ID 0428e1fd-3e1b-44fe-83fe-cf6be0915552RxCUI 259176, 1359022, 1359023, 1359025
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450090312200followed by a unit qualifier and the quantityPackage 50090-3122-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Junel 21 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 Fi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076064
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 Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9028 |
| Loestrin Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Women's Health LLC | 51285-128 |
| Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarate | — | Kit | Proficient Rx LP | 63187-890 |