Prescription drug · ANDA
Xulane (Norelgestromin and ethinyl estradiol) NDC 50090-1683
Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d · Patch · Transdermal · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1683-0 | 5009016830050090168300 | 3 POUCH in 1 CARTON (50090-1683-0) / 1 d in 1 POUCHMarketed from Feb 6, 2015 |
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)
- Xulane
- Generic name (nonproprietary)
- norelgestromin and ethinyl estradiol
- Active ingredients
- Norelgestromin — 150 ug/dEthinyl estradiol — 35 ug/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200910
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50090-1683_ebc72113-be27-4819-9f7d-3ba574452d8eSPL ID ebc72113-be27-4819-9f7d-3ba574452d8eSPL set ID adcf17ef-e60b-48a4-9478-3998dab2bbbdRxCUI 1534809, 1536586UNII 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
N450090168300followed by a unit qualifier and the quantityPackage 50090-1683-00. 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)
Xulane 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: Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m 2 [see Contraindications (4) , Warnings and Precautions (5.1) and Clinical Studies (14) ] . Xulane 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: Xulane may be less effective in pr…
Excerpt only. Read the full label for complete information.
About NDC 50090-1683
- What is NDC 50090-1683?
- 50090-1683 is the product NDC for Xulane, Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d patch, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xulane (Norelgestromin and ethinyl estradiol).
- What is the active ingredient?
- Norelgestromin, Ethinyl estradiol.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xulane?
- 1 other product NDC are listed under this name. See all Xulane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xulane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xulanenorelgestromin and ethinyl estradiol | Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3340 | 00378-3340-53 |
Other NDCs under ANDA 200910
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 |
|---|---|---|---|---|
| Xulanenorelgestromin and ethinyl estradiol | Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3340 |