NDC codes

FDA NDC Directory
Product NDC (as listed)16714-347Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0347Add 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
16714-347-01167140347011 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-347-02167140347021 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-347-03167140347033 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACKMarketed from Dec 22, 2011
16714-347-04167140347046 BLISTER PACK in 1 CARTON (16714-347-04) / 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)
Philith
Generic name (nonproprietary)
norethindrone and ethinyl estradiol tablets
Dosage form
Kit
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090947
Marketing start
Listing expires
Identifiers
Product ID 16714-347_bca1e775-2fc3-43df-8c55-e4e7b959f4fbSPL ID bca1e775-2fc3-43df-8c55-e4e7b959f4fbSPL set ID 77b8d3ef-f3ac-4148-84f0-f6cb327c9f78RxCUI 238015, 748797, 749736, 1235874

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

N416714034701 followed by a unit qualifier and the quantity

Package 16714-0347-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Oral contraceptives 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Accidental Pregnancy in the First Year of C…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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