Prescription drug · ANDA
Dasetta 1/35 NDC 16714-348
norethindrone and ethinyl estradiol · Kit · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-348-01 | 16714034801 | 1 BLISTER PACK in 1 PACKET (16714-348-01) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011 | |
| 16714-348-02 | 16714034802 | 1 BLISTER PACK in 1 CARTON (16714-348-02) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011 | |
| 16714-348-03 | 16714034803 | 3 BLISTER PACK in 1 CARTON (16714-348-03) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011 | |
| 16714-348-04 | 16714034804 | 6 BLISTER PACK in 1 CARTON (16714-348-04) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011 |
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)
- Dasetta 1/35
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090948
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-348_79bd4392-8850-4495-862b-19f391610f3cSPL ID 79bd4392-8850-4495-862b-19f391610f3cSPL set ID bfadc9b6-1dd6-4bf3-af5f-b50fbdae55d3RxCUI 312033, 748797, 749858, 1300538
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
N416714034801followed by a unit qualifier and the quantityPackage 16714-0348-01. 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 DASETTA ™ 1/35 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 combination 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. Adapted from Hatcher et al, 1998, Ref. #1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected interc…
Excerpt only. Read the full label for complete information.