Prescription drug · ANDA
Nortrel 28 Day (Norethindrone and ethinyl estradiol) NDC 0555-9008
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9008-67 | 0055590086700555900867 | 3 POUCH in 1 CARTON (0555-9008-67) / 1 BLISTER PACK in 1 POUCH (0555-9008-79) / 1 KIT in 1 BLISTER PACKMarketed from Jun 6, 2001 |
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 28 DaySuffix: 28 Day
- 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 072695
- Marketing start
- Listing expires
- Identifiers
- Product ID 0555-9008_9ac007e4-792d-4122-8daf-456dea28f82fSPL ID 9ac007e4-792d-4122-8daf-456dea28f82fSPL set ID 140c50d6-c931-423a-9aa0-526eae7ab93cRxCUI 310463, 312033, 748797, 749858, 749869, 749879, 751868, 751870, 751871UNII T18F433X4S, 423D2T571U
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
N400555900867followed by a unit qualifier and the quantityPackage 00555-9008-67. 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 Nortrel 1/35 and Nortrel 0.5/35 Tablets are 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 Unintended Pregnancy During the First Year of Typical Use and the First Yea…
Excerpt only. Read the full label for complete information.
About NDC 0555-9008
- What is NDC 0555-9008?
- 0555-9008 is the product NDC for Nortrel 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?
- Nortrel 28 Day (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 Nortrel 28 Day?
- 2 other product NDCs are listed under this name. See all Nortrel 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 Nortrel 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) |
|---|---|---|---|---|---|
| Nortrel 28 Daynorethindrone and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9010 | 00555-9010-58 |
| Nortrel 28 Daynorethindrone and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-3229 | 50090-3229-00 |
Other NDCs under ANDA 072695
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 |
|---|---|---|---|---|
| Nortrel 28 Daynorethindrone and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-3229 |