Prescription drug · ANDA
Zafemy (Norelgestromin and ethinyl estradiol) NDC 72162-2220
Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d · Patch · Transdermal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2220-1 | 7216222200172162222001 | 3 POUCH in 1 CARTON (72162-2220-1) / 1 PATCH in 1 POUCH (72162-2220-2) / 7 d in 1 PATCHMarketed from Jan 5, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213950
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 72162-2220_30c594bc-5a53-44ba-9f2b-ab6bdc637032SPL ID 30c594bc-5a53-44ba-9f2b-ab6bdc637032SPL set ID 77230a20-4269-4abf-ae2a-ac5ccafef565RxCUI 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
N472162222001followed by a unit qualifier and the quantityPackage 72162-2220-01. 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)
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 p…
Excerpt only. Read the full label for complete information.
About NDC 72162-2220
- What is NDC 72162-2220?
- 72162-2220 is the product NDC for Zafemy, Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d patch, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zafemy (Norelgestromin and Ethinyl Estradiol).
- What is the active ingredient?
- Norelgestromin, Ethinyl estradiol.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zafemy?
- 2 other product NDCs are listed under this name. See all Zafemy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zafemy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zafemynorelgestromin and ethinyl estradiol | Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d | PatchTransdermal | AvKARE | 42291-930 | 42291-0930-03 |
| Zafemynorelgestromin and ethinyl estradiol | Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d | PatchTransdermal | Amneal Pharmaceuticals LLC | 65162-358 | 65162-0358-03 |
Other NDCs under ANDA 213950
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 |
|---|---|---|---|---|
| Norelgestromin and Ethinly Estradiol | Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d | PatchTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1521 |
| 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 | Amneal Pharmaceuticals LLC | 65162-358 |