NDC codes

FDA NDC Directory
Product NDC (as listed)0555-9043Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00555-9043Add 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
0555-9043-58005559043586 POUCH in 1 CARTON (0555-9043-58) / 1 BLISTER PACK in 1 POUCH (0555-9043-79) / 1 KIT in 1 BLISTER PACKMarketed from Oct 22, 1999

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)
Apri 28 DaySuffix: 28 Day
Generic name (nonproprietary)
desogestrel and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075256
Marketing start
Listing expires
Identifiers
Product ID 0555-9043_06176d8d-c9e2-4912-ab6d-ecb3d5e514d8SPL ID 06176d8d-c9e2-4912-ab6d-ecb3d5e514d8SPL set ID a9e08f9b-9862-4c2c-8302-53dc82d85126RxCUI 240707, 748797, 749848, 753482

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

N400555904358 followed by a unit qualifier and the quantity

Package 00555-9043-58. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Apri ® (desogestrel and ethinyl estradiol tablets USP) 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 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 these methods can result in lower failure rates. In a clinical trial with Apri (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075256

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

FDA NDC Directory listings under ANDA 075256
ProductStrengthForm · routeLabelerProduct NDC
Reclipsen 28 Daydesogestrel and ethinyl estradiol—KitTeva Pharmaceuticals USA, Inc.0093-3304
Apri 28 Daydesogestrel and ethinyl estradiol—KitA-S Medication Solutions50090-2481

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