NDC codes

FDA NDC Directory
Product NDC (as listed)0555-9066Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00555-9066Add 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 NDC11-digit (billing)PackageCopy
0555-9066-6700555906667005559066673 POUCH in 1 CARTON (0555-9066-67) / 1 BLISTER PACK in 1 POUCH (0555-9066-79) / 1 KIT in 1 BLISTER PACKMarketed from Oct 4, 2004

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)
Aranelle
Generic name (nonproprietary)
norethindrone and ethinyl estradiol
Dosage form
Kit
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076783
Marketing start
Listing expires
Identifiers
Product ID 0555-9066_2ac158f0-30db-4d93-8387-ad314cabaa66SPL ID 2ac158f0-30db-4d93-8387-ad314cabaa66SPL set ID 0beef9d3-8326-48cf-b89a-fa794902c6c1RxCUI 310463, 312033, 748797, 750267, 823777

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

N400555906667 followed by a unit qualifier and the quantity

Package 00555-9066-67. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. 1 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: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGN…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0555-9066

What is NDC 0555-9066?
0555-9066 is the product NDC for Aranelle kit, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aranelle (Norethindrone and ethinyl estradiol).
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aranelle?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in