What is NDC 51862-646?

51862-646 is the product NDC for Tri-Nymyo kit, listed with the FDA by Mayne Pharma Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tri-Nymyo (Norgestimate and Ethinyl Estradiol).

Mayne Pharma Inc., NDC labeler code 51862. 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-Nymyo?

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.

Tri-Nymyo NDC 51862-646 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-646Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0646Add 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
51862-646-01	5186206460151862064601	1 BLISTER PACK in 1 PACKET (51862-646-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 24, 2020
51862-646-02	5186206460251862064602	1 BLISTER PACK in 1 CARTON (51862-646-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 24, 2020
51862-646-03	5186206460351862064603	3 BLISTER PACK in 1 CARTON (51862-646-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 24, 2020
51862-646-06	5186206460651862064606	6 BLISTER PACK in 1 CARTON (51862-646-06) / 1 KIT in 1 BLISTER PACKMarketed from Oct 24, 2020

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-Nymyo
Generic name (nonproprietary): norgestimate and ethinyl estradiol
Dosage form: Kit
Labeler: Mayne Pharma Inc.NDC labeler code 51862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090524
Marketing start: Oct 24, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 51862-646_0b6d819d-063f-41a6-a62b-ffb2a62e5dceSPL ID 0b6d819d-063f-41a6-a62b-ffb2a62e5dceSPL set ID b13800f2-618f-468d-b8a5-2fc00595db61RxCUI 240128, 406396, 687424, 748797, 749784, 2471314

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

N451862064601 followed by a unit qualifier and the quantity

Package 51862-0646-01. 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 Dec 8, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Nymyo 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-Nymyo 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-Nymyo Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] . 1.2 Acen Tri-Nymyo is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who ha…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51862-646

What is NDC 51862-646?: 51862-646 is the product NDC for Tri-Nymyo kit, listed with the FDA by Mayne Pharma Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tri-Nymyo (Norgestimate and Ethinyl Estradiol).
Who is the labeler?: Mayne Pharma Inc., NDC labeler code 51862. 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-Nymyo?: 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
Product	Strength	Form · route	Labeler	Product NDC
Tri-Linyahnorgestimate and ethinyl estradiol	—	Kit	Northstar Rx LLC	16714-363

Tri-Nymyo (Norgestimate and ethinyl estradiol) NDC 51862-646