Kelnor 1/35 NDC 0555-9064

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-9064Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-9064Add 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
0555-9064-58	00555906458	6 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACKMarketed from Jun 20, 2005

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): Kelnor 1/35
Generic name (nonproprietary): ethynodiol diacetate 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 076785
Marketing start: Jun 20, 2005
Listing expires: Dec 31, 2026
Identifiers: Product ID 0555-9064_a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3SPL ID a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3SPL set ID 96a73786-22b1-457e-be73-80b699996d40RxCUI 310228, 748797, 748804, 753483

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

N400555906458 followed by a unit qualifier and the quantity

Package 00555-9064-58. 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 Oct 19, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets) is 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 1 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 and progestogen implants and injections, 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 PREGNANC…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076785

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

FDA NDC Directory listings under ANDA 076785
Product	Strength	Form · route	Labeler	Product NDC
Kelnor 1/35ethynodiol diacetate and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-2191