Prescription drug · ANDA
norelgestromin and ethinyl estradiol NDC 70710-1190
Norelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mg · Patch · Transdermal · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1190-3 | 70710119003 | 3 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCHMarketed from Nov 21, 2023 |
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)
- norelgestromin and ethinyl estradiol
- Generic name (nonproprietary)
- norelgestromin and ethinyl estradiol
- Active ingredients
- Norelgestromin — 150 ug/mgEthinyl estradiol — 35 ug/mg
- Dosage form
- Patch
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214594
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70710-1190_404277f1-4343-462c-b508-10c22dc7bc2cSPL ID 404277f1-4343-462c-b508-10c22dc7bc2cSPL set ID 10fa1458-c8ed-4197-922a-1ba7271d2b02RxCUI 1534809UNII R0TAY3X631, 423D2T571UUPC 0370710119034
- 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
N470710119003followed by a unit qualifier and the quantityPackage 70710-1190-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Norelgestromin and ethinyl estradiol transdermal system 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: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m2 [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) and Clinical Studies ( 14 ) ]. Norelgestromin and ethinyl estradiol transdermal system is an estrogen/progestin combination hormonal contraceptive (…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214594
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 ethinyl estradiol | Norelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mg | PatchTransdermal | Zydus Lifesciences Limited | 70771-1777 |