NDC codes

FDA NDC Directory
Product NDC (as listed)16714-440Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0440Add 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
16714-440-01167140440011 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-440-02167140440021 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2020
16714-440-03167140440033 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2020
16714-440-04167140440046 BLISTER PACK in 1 CARTON (16714-440-04) / 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)
Deblitane
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 202014
Marketing start
Listing expires
Identifiers
Product ID 16714-440_843ad7a1-bcee-4568-acd1-31673b04b913SPL ID 843ad7a1-bcee-4568-acd1-31673b04b913SPL set ID e75367ff-78af-4bd2-a99d-d291cb1d21ebRxCUI 198042, 748961, 1539953

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

N416714044001 followed by a unit qualifier and the quantity

Package 16714-0440-01. 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 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 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-440

What is NDC 16714-440?
16714-440 is the product NDC for Deblitane (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?
Deblitane (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 Deblitane?
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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in