NDC codes

FDA NDC Directory
Product NDC (as listed)65862-776Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0776Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
65862-776-28658620776281 BLISTER PACK in 1 CARTON (65862-776-28) / 1 KIT in 1 BLISTER PACKMarketed from Jul 7, 2016
65862-776-85658620776853 BLISTER PACK in 1 CARTON (65862-776-85) / 1 KIT in 1 BLISTER PACKMarketed from Jul 7, 2016
65862-776-86658620776866 BLISTER PACK in 1 CARTON (65862-776-86) / 1 KIT in 1 BLISTER PACKMarketed from Jul 7, 2016
65862-776-87658620776871 POUCH in 1 CARTON (65862-776-87) / 1 KIT in 1 POUCHMarketed from Jul 7, 2016
65862-776-88658620776883 POUCH in 1 CARTON (65862-776-88) / 1 KIT in 1 POUCHMarketed from Jul 7, 2016
65862-776-92658620776926 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
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

N465862077628 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205449

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205449
ProductStrengthForm · routeLabelerProduct NDC
VyLibranorgestimate and ethinyl estradiol—KitAfaxys Pharma, LLC50102-235

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