Prescription drug · ANDA
Elinest NDC 16714-365
norgestrel and ethinyl estradiol · Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-365-01 | 16714036501 | 1 BLISTER PACK in 1 PACKET (16714-365-01) / 1 KIT in 1 BLISTER PACKMarketed from Jan 7, 2012 | |
| 16714-365-02 | 16714036502 | 1 BLISTER PACK in 1 CARTON (16714-365-02) / 1 KIT in 1 BLISTER PACKMarketed from Jan 7, 2012 | |
| 16714-365-03 | 16714036503 | 3 BLISTER PACK in 1 CARTON (16714-365-03) / 1 KIT in 1 BLISTER PACKMarketed from Jan 7, 2012 | |
| 16714-365-04 | 16714036504 | 6 BLISTER PACK in 1 CARTON (16714-365-04) / 1 KIT in 1 BLISTER PACKMarketed from Jan 7, 2012 |
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)
- Elinest
- Generic name (nonproprietary)
- norgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091105
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-365_cf47f8b4-e64e-4128-a197-54bcce596aa1SPL ID cf47f8b4-e64e-4128-a197-54bcce596aa1SPL set ID aa7f4a83-71cf-4306-b0a1-01784f67bae2RxCUI 311359, 748797, 749786, 1305089
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
N416714036501followed by a unit qualifier and the quantityPackage 16714-0365-01. 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 ELINEST TM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
Excerpt only. Read the full label for complete information.