Prescription drug · ANDA
Junel Fe 28 Day NDC 72789-450
norethindrone acetate and ethinyl estradiol and ferrous fumarate · Kit · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-450-79 | 7278904507972789045079 | 28 BLISTER PACK in 1 POUCH (72789-450-79) / 1 KIT in 1 BLISTER PACKMarketed from Nov 8, 2024 |
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 28 DaySuffix: Fe 28 Day
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076081
- Marketing start
- Listing expires
- Identifiers
- Product ID 72789-450_525a6380-51e2-1cdc-e063-6394a90a0a35SPL ID 525a6380-51e2-1cdc-e063-6394a90a0a35SPL set ID 93a2f8c9-3550-42ec-8f76-3ac9badf4bb2RxCUI 259176, 1358762, 1358763, 1358765UPC 0372789450797
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
N472789045079followed by a unit qualifier and the quantityPackage 72789-0450-79. 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.
About NDC 72789-450
- What is NDC 72789-450?
- 72789-450 is the product NDC for Junel Fe 28 Day kit, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Junel Fe 28 Day (Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate).
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Junel Fe 28 Day?
- 5 other product NDCs are listed under this name. See all Junel Fe 28 Day NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Junel Fe 28 Day products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9026 | 00555-9026-58 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9028 | 00555-9028-58 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | A-S Medication Solutions | 50090-3122 | 50090-3122-00 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | A-S Medication Solutions | 50090-3237 | 50090-3237-00 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Bryant Ranch Prepack | 63629-5628 | 63629-5628-01 |
Other NDCs under ANDA 076081
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 1/20norethindrone acetate and ethinyl estradiol, and ferrous fumarate | — | Kit | Preferred Pharmaceuticals Inc. | 68788-6832 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9026 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | A-S Medication Solutions | 50090-3237 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Bryant Ranch Prepack | 63629-5628 |
| Loestrin Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Women's Health LLC | 51285-125 |