NDC codes

FDA NDC Directory
Product NDC (as listed)16714-359Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0359Add 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
16714-359-0116714035901167140359011 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-359-0216714035902167140359021 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-359-0316714035903167140359033 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-359-0416714035904167140359046 BLISTER PACK in 1 CARTON (16714-359-04) / 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)
Falmina
Generic name (nonproprietary)
levonorgestrel and ethinyl estradiol
Dosage form
Kit
Labeler
Northstar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090721
Marketing start
Listing expires
Identifiers
Product ID 16714-359_a0973aa1-ac56-4811-8221-cdf0e79c3f90SPL ID a0973aa1-ac56-4811-8221-cdf0e79c3f90SPL set ID cf6f069e-4b78-4adb-b5be-100b9d85aab7RxCUI 242297, 748797, 748868, 1304988

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

N416714035901 followed by a unit qualifier and the quantity

Package 16714-0359-01. 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 FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cyc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-359

What is NDC 16714-359?
16714-359 is the product NDC for Falmina 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?
Falmina (Levonorgestrel 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 Falmina?
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.

Other NDCs under ANDA 090721

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090721
ProductStrengthForm · routeLabelerProduct NDC
Luteralevonorgestrel and ethinyl estradiol—KitDr. Reddys Laboratories Inc.55741-005

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