Nymyo NDC 51862-645

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-645Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0645Add 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
51862-645-01	51862064501	1 BLISTER PACK in 1 PACKET (51862-645-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 2020
51862-645-02	51862064502	1 BLISTER PACK in 1 CARTON (51862-645-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 2020
51862-645-03	51862064503	3 BLISTER PACK in 1 CARTON (51862-645-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 2020
51862-645-06	51862064506	6 BLISTER PACK in 1 CARTON (51862-645-06) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 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): Nymyo
Generic name (nonproprietary): norgestimate and ethinyl estradiol
Dosage form: Kit
Labeler: Mayne Pharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090523
Marketing start: Oct 11, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 51862-645_0048909e-ca81-45c9-9f5c-c5891f9bc85eSPL ID 0048909e-ca81-45c9-9f5c-c5891f9bc85eSPL set ID a522aff5-b02f-4e18-bf59-40bb0399e6feRxCUI 240128, 748797, 749860, 2468058

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

N451862064501 followed by a unit qualifier and the quantity

Package 51862-0645-01. 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)

Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Nymyo 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
Mono-Linyahnorgestimate and ethinyl estradiol	—	Kit	Northstar Rx LLC	16714-360