NDC codes

FDA NDC Directory
Product NDC (as listed)16714-441Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0441Add 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
16714-441-01167140441011 BLISTER PACK in 1 PACKET (16714-441-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-441-02167140441021 BLISTER PACK in 1 CARTON (16714-441-02) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2020
16714-441-03167140441033 BLISTER PACK in 1 CARTON (16714-441-03) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2020
16714-441-04167140441046 BLISTER PACK in 1 CARTON (16714-441-04) / 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)
Sharobel
Generic name (nonproprietary)
norethindrone
Dosage form
Kit
Labeler
Northstar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200961
Marketing start
Listing expires
Identifiers
Product ID 16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9cSPL ID bc5880ea-5359-4f40-a2e5-7af0b1131a9cSPL set ID a96f5194-ad2a-4783-a9a9-22a288caff25RxCUI 198042, 748961, 1539955

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

N416714044101 followed by a unit qualifier and the quantity

Package 16714-0441-01. 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 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the Fi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-441

What is NDC 16714-441?
16714-441 is the product NDC for Sharobel (norethindrone) 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?
Sharobel (Norethindrone).
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 Sharobel?
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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