Nortrel 28 Day NDC 0555-9008

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-9008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-9008Add 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
0555-9008-67	00555900867	3 POUCH in 1 CARTON (0555-9008-67) / 1 BLISTER PACK in 1 POUCH (0555-9008-79) / 1 KIT in 1 BLISTER PACKMarketed from Jun 6, 2001

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): Nortrel 28 DaySuffix: 28 Day
Generic name (nonproprietary): norethindrone and ethinyl estradiol
Dosage form: Kit
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072695
Marketing start: Jun 6, 2001
Listing expires: Dec 31, 2027
Identifiers: Product ID 0555-9008_9ac007e4-792d-4122-8daf-456dea28f82fSPL ID 9ac007e4-792d-4122-8daf-456dea28f82fSPL set ID 140c50d6-c931-423a-9aa0-526eae7ab93cRxCUI 310463, 312033, 748797, 749858, 749869, 749879, 751868, 751870, 751871UNII T18F433X4S, 423D2T571U

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

N400555900867 followed by a unit qualifier and the quantity

Package 00555-9008-67. 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, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nortrel 1/35 and Nortrel 0.5/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Yea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072695

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

FDA NDC Directory listings under ANDA 072695
Product	Strength	Form · route	Labeler	Product NDC
Nortrel 28 Daynorethindrone and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-3229