Falmina NDC 16714-359

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 NDC	11-digit (billing)	Package
16714-359-01	16714035901	1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-359-02	16714035902	1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-359-03	16714035903	3 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013
16714-359-04	16714035904	6 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 LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090721
Marketing start: Sep 13, 2013
Listing expires: Dec 31, 2026
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 Feb 21, 2025.

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)

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
Product	Strength	Form · route	Labeler	Product NDC
Luteralevonorgestrel and ethinyl estradiol	—	Kit	Dr. Reddys Laboratories Inc.	55741-005