Mono-Linyah NDC 16714-360

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-360Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0360Add 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
16714-360-01	16714036001	1 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACKMarketed from May 23, 2012
16714-360-02	16714036002	1 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACKMarketed from May 23, 2012
16714-360-03	16714036003	3 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACKMarketed from May 23, 2012
16714-360-04	16714036004	6 BLISTER PACK in 1 CARTON (16714-360-04) / 1 KIT in 1 BLISTER PACKMarketed from May 23, 2012

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): Mono-Linyah
Generic name (nonproprietary): norgestimate and ethinyl estradiol
Dosage form: Kit
Labeler: Northstar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090523
Marketing start: May 23, 2012
Listing expires: Dec 31, 2026
Identifiers: Product ID 16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1SPL ID e9022492-18a7-44e1-9a89-45a4c06c72f1SPL set ID 84a20017-344b-4684-a915-c85a55fcbbcbRxCUI 240128, 748797, 749860, 1365899

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

N416714036001 followed by a unit qualifier and the quantity

Package 16714-0360-01. 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 Jan 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Mono-Linyah is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Mono-Linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090523

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

FDA NDC Directory listings under ANDA 090523
Product	Strength	Form · route	Labeler	Product NDC
Mono-Linyahnorgestimate and ethinyl estradiol	—	Kit	Redpharm Drug	67296-2329
Mono-Linyahnorgestimate and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-4881
Nymyonorgestimate and ethinyl estradiol	—	Kit	Mayne Pharma Inc.	51862-645