Prescription drug · ANDA
Junel Fe 1/20 NDC 68788-6832
norethindrone acetate and ethinyl estradiol, and ferrous fumarate · Kit · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-6832-2 | 6878868320268788683202 | 6 BLISTER PACK in 1 CARTON (68788-6832-2) / 1 KIT in 1 BLISTER PACKMarketed from Nov 21, 2016 |
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 1/20
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076081
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-6832_01765aa5-7e4e-45b9-bd18-3c692c36c958SPL ID 01765aa5-7e4e-45b9-bd18-3c692c36c958SPL set ID 75bb0024-8f1a-4036-9acd-006ea430f3b7RxCUI 259176, 1358762, 1358763, 1358765
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
N468788683202followed by a unit qualifier and the quantityPackage 68788-6832-02. 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 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 Fir…
Excerpt only. Read the full label for complete information.
About NDC 68788-6832
- What is NDC 68788-6832?
- 68788-6832 is the product NDC for Junel Fe 1/20 kit, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Junel Fe 1/20 (Norethindrone acetate and ethinyl estradiol, and ferrous fumarate).
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 1/20?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 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 |
| Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | PD-Rx Pharmaceuticals, Inc. | 72789-450 |
| Loestrin Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Teva Women's Health LLC | 51285-125 |