NDC codes

FDA NDC Directory
Product NDC (as listed)16714-363Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0363Add 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
16714-363-0116714036301167140363011 BLISTER PACK in 1 PACKET (16714-363-01) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 2012
16714-363-0216714036302167140363021 BLISTER PACK in 1 CARTON (16714-363-02) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 2012
16714-363-0316714036303167140363033 BLISTER PACK in 1 CARTON (16714-363-03) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 2012
16714-363-0416714036304167140363046 BLISTER PACK in 1 CARTON (16714-363-04) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 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)
Tri-Linyah
Generic name (nonproprietary)
norgestimate 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 090524
Marketing start
Listing expires
Identifiers
Product ID 16714-363_9da2c056-16f5-4549-9067-cb67408872f5SPL ID 9da2c056-16f5-4549-9067-cb67408872f5SPL set ID b71a2b34-95bf-4430-83a0-1a4d1218ea3cRxCUI 240128, 406396, 687424, 748797, 749784, 1311535

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

N416714036301 followed by a unit qualifier and the quantity

Package 16714-0363-01. 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)

Tri-Linyah is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Linyah is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-Linyah is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, wh…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-363

What is NDC 16714-363?
16714-363 is the product NDC for Tri-Linyah 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?
Tri-Linyah (Norgestimate 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 Tri-Linyah?
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 090524

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

FDA NDC Directory listings under ANDA 090524
ProductStrengthForm · routeLabelerProduct NDC
Tri-Nymyonorgestimate and ethinyl estradiol—KitMayne Pharma Inc.51862-646

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