NDC codes

FDA NDC Directory
Product NDC (as listed)16714-346Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0346Add 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
16714-346-0116714034601167140346011 BLISTER PACK in 1 PACKET (16714-346-01) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-346-0216714034602167140346021 BLISTER PACK in 1 CARTON (16714-346-02) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-346-0316714034603167140346033 BLISTER PACK in 1 CARTON (16714-346-03) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-346-0416714034604167140346046 BLISTER PACK in 1 CARTON (16714-346-04) / 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 7/7/7
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 090946
Marketing start
Listing expires
Identifiers
Product ID 16714-346_ff1aec32-4fa6-4238-b017-d3adc8d6d343SPL ID ff1aec32-4fa6-4238-b017-d3adc8d6d343SPL set ID da52e74a-1baf-4a33-a068-b49176700320RxCUI 310463, 312033, 392662, 748797, 749852, 1235867

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

N416714034601 followed by a unit qualifier and the quantity

Package 16714-0346-01. 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™ 7/7/7 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 combined 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. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-346

What is NDC 16714-346?
16714-346 is the product NDC for Dasetta 7/7/7 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 7/7/7 (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 7/7/7?
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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