Prescription drug · ANDA
Tri-Linyah NDC 16714-363
norgestimate and ethinyl estradiol · Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-363-01 | 16714036301 | 1 BLISTER PACK in 1 PACKET (16714-363-01) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 2012 | |
| 16714-363-02 | 16714036302 | 1 BLISTER PACK in 1 CARTON (16714-363-02) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 2012 | |
| 16714-363-03 | 16714036303 | 3 BLISTER PACK in 1 CARTON (16714-363-03) / 1 KIT in 1 BLISTER PACKMarketed from May 30, 2012 | |
| 16714-363-04 | 16714036304 | 6 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 LLC
- 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
N416714036301followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 090524
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tri-Nymyonorgestimate and ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-646 |