NDC codes

FDA NDC Directory
Product NDC (as listed)16714-348Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0348Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
16714-348-0116714034801167140348011 BLISTER PACK in 1 PACKET (16714-348-01) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-348-0216714034802167140348021 BLISTER PACK in 1 CARTON (16714-348-02) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-348-0316714034803167140348033 BLISTER PACK in 1 CARTON (16714-348-03) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-348-0416714034804167140348046 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 LLCNDC labeler code 16714
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

N416714034801 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 16714-348

What is NDC 16714-348?
16714-348 is the product NDC for Dasetta 1/35 kit, listed with the FDA by Northstar Rx LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dasetta 1/35 (Norethindrone and Ethinyl Estradiol).
Who is the labeler?
Northstar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dasetta 1/35?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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