Prescription drug · ANDA
Tri-Mili NDC 65862-777
norgestimate and ethinyl estradiol · Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-777-28 | 65862077728 | 1 BLISTER PACK in 1 CARTON (65862-777-28) / 1 KIT in 1 BLISTER PACKMarketed from Jul 6, 2016 | |
| 65862-777-85 | 65862077785 | 3 BLISTER PACK in 1 CARTON (65862-777-85) / 1 KIT in 1 BLISTER PACKMarketed from Jul 6, 2016 | |
| 65862-777-86 | 65862077786 | 6 BLISTER PACK in 1 CARTON (65862-777-86) / 1 KIT in 1 BLISTER PACKMarketed from Jul 6, 2016 | |
| 65862-777-87 | 65862077787 | 1 POUCH in 1 CARTON (65862-777-87) / 1 KIT in 1 POUCHMarketed from Jul 6, 2016 | |
| 65862-777-88 | 65862077788 | 3 POUCH in 1 CARTON (65862-777-88) / 1 KIT in 1 POUCHMarketed from Jul 6, 2016 | |
| 65862-777-92 | 65862077792 | 6 POUCH in 1 CARTON (65862-777-92) / 1 KIT in 1 POUCHMarketed from Jul 6, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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-Mili
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205441
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-777_4f010d17-76f4-4320-a0e3-1f03c594422dSPL ID 4f010d17-76f4-4320-a0e3-1f03c594422dSPL set ID 22cfceff-0429-466f-a015-33cfdc505d44RxCUI 240128, 406396, 687424, 748797, 749784, 1800500
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
N465862077728followed by a unit qualifier and the quantityPackage 65862-0777-28. 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)
Tri-Mili is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Mili is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Mili should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Mili tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-Mili is indicated for the treatment o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205441
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 |
|---|---|---|---|---|
| Tri-VyLibranorgestimate and ethinyl estradiol | — | Kit | Afaxys Pharma, LLC | 50102-233 |