What is NDC 82804-172?

82804-172 is the product NDC for Junel 21 Day, Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Junel 21 Day (Norethindrone Acetate and Ethinyl Estradiol).

What is the active ingredient?

Norethindrone acetate, Ethinyl estradiol.

Proficient Rx LP, NDC labeler code 82804. 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 21 Day?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Junel 21 Day NDC 82804-172 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-172Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0172Add 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
82804-172-21	8280401722182804017221	3 POUCH in 1 CARTON (82804-172-21) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Dec 6, 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 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: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076380
Marketing start: Sep 18, 2003
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 82804-172_56e91ad4-f31b-494d-9e75-6dd4f396779cSPL ID 56e91ad4-f31b-494d-9e75-6dd4f396779cSPL set ID 56e91ad4-f31b-494d-9e75-6dd4f396779cRxCUI 1358762, 1358776, 1358780UNII 9S44LIC7OJ, 423D2T571UUPC 0382804172214
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

N482804017221 followed by a unit qualifier and the quantity

Package 82804-0172-21. 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 Dec 1, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 82804-172

What is NDC 82804-172?: 82804-172 is the product NDC for Junel 21 Day, Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Junel 21 Day (Norethindrone Acetate and Ethinyl Estradiol).
What is the active ingredient?: Norethindrone acetate, Ethinyl estradiol.
Who is the labeler?: Proficient Rx LP, NDC labeler code 82804. 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 21 Day?: 2 other product NDCs are listed under this name. See all Junel 21 Day NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Junel 21 Day NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Junel 21 Daynorethindrone acetate and ethinyl estradiol	Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-9025	00555-9025-42
Junel 21 Daynorethindrone acetate and ethinyl estradiol	Norethindrone acetate 1.5 mg/1; Ethinyl estradiol 30 ug/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-9027	00555-9027-42

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	Teva Pharmaceuticals USA, Inc.	0555-9025
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