Prescription drug · ANDA
Pimtrea NDC 16714-404
desogestrel/ethinyl estradiol and ethinyl estradiol · Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-404-01 | 16714040401 | 1 BLISTER PACK in 1 PACKET (16714-404-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013 | |
| 16714-404-02 | 16714040402 | 1 BLISTER PACK in 1 CARTON (16714-404-02) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013 | |
| 16714-404-03 | 16714040403 | 3 BLISTER PACK in 1 CARTON (16714-404-03) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013 | |
| 16714-404-04 | 16714040404 | 6 BLISTER PACK in 1 CARTON (16714-404-04) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013 |
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)
- Pimtrea
- Generic name (nonproprietary)
- desogestrel/ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091247
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-404_12f60f95-d164-4964-bf6a-dc3cfb42bac0SPL ID 12f60f95-d164-4964-bf6a-dc3cfb42bac0SPL set ID b716fd2a-b186-447a-85bd-6302284d14e5RxCUI 248310, 249357, 748797, 759743, 1438778
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
N416714040401followed by a unit qualifier and the quantityPackage 16714-0404-01. 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 PIMTREA TM (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is 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 II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a met…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091247
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.