Prescription drug · ANDA
Simpesse NDC 65862-864
levonorgestrel and ethinyl estradiol and ethinyl estradiol · Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-864-95 | 65862086495 | 2 POUCH in 1 CARTON (65862-864-95) / 1 BLISTER PACK in 1 POUCH (65862-864-94) / 1 KIT in 1 BLISTER PACKMarketed from Apr 7, 2017 |
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)
- Simpesse
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206851
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-864_bd9d6e25-de56-422b-9155-89378c5b943fSPL ID bd9d6e25-de56-422b-9155-89378c5b943fSPL set ID abea62b3-6a55-40a4-9e68-1ee9801e0f2cRxCUI 238019, 248310, 749761, 1918056
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
N465862086495followed by a unit qualifier and the quantityPackage 65862-0864-95. 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)
Simpesse ® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Simpesse is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.