Prescription drug · ANDA
Nortrel 7/7/7 (28 Day Regimen) (Norethindrone and ethinyl estradiol) NDC 0555-9012
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9012-58 | 0055590125800555901258 | 6 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACKMarketed from Jan 2, 2003 |
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 7/7/7 (28 Day Regimen)Suffix: (28 Day Regimen)
- 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 075478
- Marketing start
- Listing expires
- Identifiers
- Product ID 0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072SPL ID 5157d13b-a384-46cb-9e9e-f3691d4f9072SPL set ID 992dcc56-90ab-4691-8114-16d47a8b9982RxCUI 310463, 312033, 392662, 748797, 749852, 762007
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
N400555901258followed by a unit qualifier and the quantityPackage 00555-9012-58. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Nortrel ® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) is 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 Unint…
Excerpt only. Read the full label for complete information.
About NDC 0555-9012
- What is NDC 0555-9012?
- 0555-9012 is the product NDC for Nortrel 7/7/7 (28 Day Regimen) 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 7/7/7 (28 Day Regimen) (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 7/7/7 (28 Day Regimen)?
- 1 other product NDC are listed under this name. See all Nortrel 7/7/7 (28 Day Regimen) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nortrel 7/7/7 (28 Day Regimen) 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 7/7/7 (28 Day Regimen)norethindrone and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-685 | 71205-0685-28 |
Other NDCs under ANDA 075478
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 7/7/7 (28 Day Regimen)norethindrone and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-685 |