Prescription drug · ANDA
Junel Fe 1.5/30 NDC 63187-890
norethindrone acetate and ethinyl estradiol, and ferrous fumarate · Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-890-28 | 63187089028 | 6 BLISTER PACK in 1 CARTON (63187-890-28) / 1 KIT in 1 BLISTER PACKMarketed from Aug 1, 2017 |
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 1.5/30
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076064
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-890_d73ad261-b388-48ac-ad8f-133af829dfbcSPL ID d73ad261-b388-48ac-ad8f-133af829dfbcSPL set ID 253c6b2e-2c93-4ee7-94a6-fd063c569c1fRxCUI 259176, 1359022, 1359023, 1359025UPC 0363187890285
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
N463187089028followed by a unit qualifier and the quantityPackage 63187-0890-28. 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 . 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 Adapted from RA Hatcher et al, Reference 7. % of Women…
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 | A-S Medication Solutions | 50090-3122 |
| 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 |