XULANE
- Product NDC
- 50090-1683
- 11-digit product format
- 500901683
- Labeler code
- 50090
- Product ID
- 50090-1683_ebc72113-be27-4819-9f7d-3ba574452d8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norelgestromin and ethinyl estradiol
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA200910
- Marketing category
- ANDA
- Marketing start
- 2014-04-16
- Substance
- ETHINYL ESTRADIOL; NORELGESTROMIN
- Active strength
- 35; 150 ug/d; ug/d
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XULANE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 35 ug/d |
| NORELGESTROMIN | 150 ug/d |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, R0TAY3X631 |
| Rxcui | 1534809, 1536586 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1683-0 | XULANE | 3 in 1 CARTON | PATCH | 3 | | 15 |
| 50090-1683-0 | XULANE | 1 d in 1 POUCH | PATCH | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1683 | XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [A-S MEDICATION SOLUTIONS] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240229_adcf17ef-e60b-48a4-9478-3998dab2bbbd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-1683-0 | 50090168300 | 3 POUCH in 1 CARTON (50090-1683-0) / 1 d in 1 POUCH | 3 pouch | 2015-02-06 | 0000-00-00 | No | No | Current |