Zafemy NDC 65162-358

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0358Add 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	Copy
65162-358-03	65162035803	3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCHMarketed from Jun 30, 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): Zafemy
Generic name (nonproprietary): norelgestromin and ethinyl estradiol
Active ingredients: Norelgestromin — 150 ug/dEthinyl estradiol — 35 ug/d
Dosage form: Patch
Route: Transdermal
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213950
Marketing start: Jun 28, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 65162-358_4370e72b-f961-453e-ab06-5d933a6f5b50SPL ID 4370e72b-f961-453e-ab06-5d933a6f5b50SPL set ID 5ee34c07-65af-42b8-a98f-e299ff90a8a1RxCUI 1534809, 2531285UNII R0TAY3X631, 423D2T571U
Pharmacologic class: Estrogen; Progestin

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 HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465162035803 followed by a unit qualifier and the quantity

Package 65162-0358-03. 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 Apr 30, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

ZAFEMY is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: ZAFEMY may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. ZAFEMY is contraindicated for use in women with BMI ≥ 30 kg/m 2 [see Contraindications (4) , Warnings and Precautions (5.1) and Clinical Studies (14) ]. ZAFEMY ® is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. (1) Limitations of Use : ZAFEMY may be less effective in pre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213950

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

FDA NDC Directory listings under ANDA 213950
Product	Strength	Form · route	Labeler	Product NDC
Zafemynorelgestromin and ethinyl estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	AvKARE	42291-930
Zafemynorelgestromin and ethinyl estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	Bryant Ranch Prepack	72162-2220
Norelgestromin and Ethinly Estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	Amneal Pharmaceuticals NY LLC	69238-1521