Nortrel 7/7/7 (28 Day Regimen) NDC 0555-9012

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-9012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-9012Add 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
0555-9012-58	00555901258	6 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACKMarketed from Jan 2, 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): Nortrel 7/7/7 (28 Day Regimen)Suffix: (28 Day Regimen)
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 075478
Marketing start: Jan 2, 2003
Listing expires: Dec 31, 2027
Identifiers: Product ID 0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072SPL ID 5157d13b-a384-46cb-9e9e-f3691d4f9072SPL set ID 992dcc56-90ab-4691-8114-16d47a8b9982RxCUI 310463, 312033, 392662, 748797, 749852, 762007

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

N400555901258 followed by a unit qualifier and the quantity

Package 00555-9012-58. 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 ® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) is 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 Unint…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075478

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

FDA NDC Directory listings under ANDA 075478
Product	Strength	Form · route	Labeler	Product NDC
Nortrel 7/7/7 (28 Day Regimen)norethindrone and ethinyl estradiol	—	Kit	Proficient Rx LP	71205-685