Junel 21 Day NDC 0555-9025

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-9025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-9025Add 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 NDC	11-digit (billing)	Package	Copy
0555-9025-42	00555902542	3 POUCH in 1 CARTON (0555-9025-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Sep 18, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 21 DaySuffix: 21 Day
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol
Active ingredients: Norethindrone acetate — 1 mg/1Ethinyl estradiol — 20 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076380
Marketing start: Sep 18, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0555-9025_254f2e35-bbeb-4134-8799-2d3fa959fe84SPL ID 254f2e35-bbeb-4134-8799-2d3fa959fe84SPL set ID 8b82ad14-580c-4145-b825-dce849f95363RxCUI 259176, 1358762, 1358763, 1358765, 1358776, 1358780, 1359022, 1359023, 1359025, 1359028, 1359030UNII 9S44LIC7OJ, 423D2T571U
Pharmacologic class: Estrogen; Progestin

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400555902542 followed by a unit qualifier and the quantity

Package 00555-9025-42. 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 Feb 27, 2025. 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 076380

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

FDA NDC Directory listings under ANDA 076380
Product	Strength	Form · route	Labeler	Product NDC
Junel 21 Daynorethindrone acetate and ethinyl estradiol	Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1	TabletOral	Proficient Rx LP	82804-172
Junel FE	Ethinyl estradiol 20 ug/1; Norethindrone acetate 1 mg/1	TabletOral	Direct_Rx	72189-215
Loestrin 21 Daynorethindrone acetate and ethinyl estradiol	Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1	TabletOral	Teva Women's Health LLC	51285-131