Prescription drug · ANDA
Tri-Legest Fe 28 Day NDC 0555-9032
norethindrone acetate and ethinyl estradiol · Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9032-70 | 00555903270 | 5 BLISTER PACK in 1 CARTON (0555-9032-70) / 1 KIT in 1 BLISTER PACKMarketed from Oct 26, 2007 |
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)
- Tri-Legest Fe 28 DaySuffix: 28 Day
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076105
- Marketing start
- Listing expires
- Identifiers
- Product ID 0555-9032_d7c6f988-bb93-48d0-90e3-9074a5185999SPL ID d7c6f988-bb93-48d0-90e3-9074a5185999SPL set ID 6f9d30d9-5553-4cbd-a099-ff045bc85821RxCUI 259176, 1358762, 1359130, 1359131, 1359132, 1359135
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
N400555903270followed by a unit qualifier and the quantityPackage 00555-9032-70. 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 Tri-Legest ® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tri-Legest ® Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest ® Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to sta…
Excerpt only. Read the full label for complete information.