Loestrin 21 Day NDC 51285-131

NDC codes

FDA NDC Directory

Product NDC (as listed)51285-131Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51285-0131Add 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
51285-131-97	51285013197	5 POUCH in 1 CARTON (51285-131-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Feb 26, 2015

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): Loestrin 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 Women's Health LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076380
Marketing start: Feb 26, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 51285-131_21f0dbf2-f0a8-447a-a975-482b4194b1ebSPL ID 21f0dbf2-f0a8-447a-a975-482b4194b1ebSPL set ID f29ebcb5-7e65-4092-bfaa-f5ec026fc255RxCUI 259176, 1358762, 1358763, 1358770, 1358776, 1358781, 1359022, 1359023, 1359026, 1359028, 1359031UNII 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

N451285013197 followed by a unit qualifier and the quantity

Package 51285-0131-97. 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 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loestrin 21 and Loestrin 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 …

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	Teva Pharmaceuticals USA, Inc.	0555-9025
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