Prescription drug · ANDA
Apri 28 Day (Desogestrel and ethinyl estradiol) NDC 0555-9043
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9043-58 | 0055590435800555904358 | 6 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
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- 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
N400555904358followed by a unit qualifier and the quantityPackage 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.
About NDC 0555-9043
- What is NDC 0555-9043?
- 0555-9043 is the product NDC for Apri 28 Day 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?
- Apri 28 Day (Desogestrel 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 Apri 28 Day?
- 1 other product NDC are listed under this name. See all Apri 28 Day NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Apri 28 Day products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Apri 28 Daydesogestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2481 | 50090-2481-00 |
Other NDCs under ANDA 075256
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Apri 28 Daydesogestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2481 |
| Reclipsen 28 Daydesogestrel and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0093-3304 |