NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3122Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-3122-0500903122006 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
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

N450090312200 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076064

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076064
ProductStrengthForm · routeLabelerProduct NDC
Junel Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate—KitTeva Pharmaceuticals USA, Inc.0555-9028
Loestrin Fe 28 Daynorethindrone acetate and ethinyl estradiol and ferrous fumarate—KitTeva Women's Health LLC51285-128
Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarate—KitProficient Rx LP63187-890

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