Prescription drug · ANDA
Mili NDC 65862-776
norgestimate and ethinyl estradiol · Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-776-28 | 65862077628 | 1 BLISTER PACK in 1 CARTON (65862-776-28) / 1 KIT in 1 BLISTER PACKMarketed from Jul 7, 2016 | |
| 65862-776-85 | 65862077685 | 3 BLISTER PACK in 1 CARTON (65862-776-85) / 1 KIT in 1 BLISTER PACKMarketed from Jul 7, 2016 | |
| 65862-776-86 | 65862077686 | 6 BLISTER PACK in 1 CARTON (65862-776-86) / 1 KIT in 1 BLISTER PACKMarketed from Jul 7, 2016 | |
| 65862-776-87 | 65862077687 | 1 POUCH in 1 CARTON (65862-776-87) / 1 KIT in 1 POUCHMarketed from Jul 7, 2016 | |
| 65862-776-88 | 65862077688 | 3 POUCH in 1 CARTON (65862-776-88) / 1 KIT in 1 POUCHMarketed from Jul 7, 2016 | |
| 65862-776-92 | 65862077692 | 6 POUCH in 1 CARTON (65862-776-92) / 1 KIT in 1 POUCHMarketed from Jul 7, 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)
- 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 205449
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-776_d407dedd-a4c1-4811-91a8-db402646613fSPL ID d407dedd-a4c1-4811-91a8-db402646613fSPL set ID 76f14485-321d-4d4f-a3b0-aab195fd0dd1RxCUI 240128, 748797, 749860, 1800499
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
N465862077628followed by a unit qualifier and the quantityPackage 65862-0776-28. 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)
Mili is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Mili tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205449
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 |
|---|---|---|---|---|
| VyLibranorgestimate and ethinyl estradiol | — | Kit | Afaxys Pharma, LLC | 50102-235 |