Prescription drug · ANDA
Necon NDC 51862-892
norethindrone and ethinyl estradiol · Kit · Oral · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-892-01 | 51862089201 | 1 BLISTER PACK in 1 PACKET (51862-892-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020 | |
| 51862-892-02 | 51862089202 | 1 BLISTER PACK in 1 CARTON (51862-892-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020 | |
| 51862-892-06 | 51862089206 | 6 BLISTER PACK in 1 CARTON (51862-892-06) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020 |
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)
- Necon
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Mayne Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091204
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-892_61a14c7a-159a-4856-b564-a97aee2bec6eSPL ID 61a14c7a-159a-4856-b564-a97aee2bec6eSPL set ID e80714f4-cdfe-4d60-a4e1-b8c7b184cc46RxCUI 310463, 748797, 749879, 751875
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451862089201followed by a unit qualifier and the quantityPackage 51862-0892-01. 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 Necon Tablets are 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 Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contrac…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091204
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.