XULANE
- Product NDC
- 0378-3340
- 11-digit product format
- 003783340
- Labeler code
- 0378
- Product ID
- 0378-3340_5cf2e689-da68-4a6a-8761-267a63244360
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norelgestromin and ethinyl estradiol
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Mylan Pharmaceuticals Inc.
- 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 |
|---|---|
| ETHINYL ESTRADIOL | 35 ug/d |
| NORELGESTROMIN | 150 ug/d |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 423D2T571U, R0TAY3X631 |
| Rxcui | 1534809, 1536586 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-3340-16 | XULANE | 7 d in 1 PATCH | PATCH | 7 | 16 | |
| 0378-3340-16 | XULANE | 1 in 1 POUCH | PATCH | 1 | 16 | |
| 0378-3340-17 | XULANE | 1 in 1 POUCH | PATCH | 1 | 16 | |
| 0378-3340-17 | XULANE | 7 d in 1 PATCH | PATCH | 7 | 16 | |
| 0378-3340-32 | XULANE | 1 in 1 CARTON | PATCH | 1 | 16 | |
| 0378-3340-53 | XULANE | 3 in 1 CARTON | PATCH | 3 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-3340-16 | EA - Each | 0378-3340 | 29a3b2df-d582-4788-94c0-84f1ce211507 | 1 | 2017-06-15 |
| 0378-3340-53 | EA - Each | 0378-3340 | fa993b2c-a314-4ad5-96f0-406dec3d5dc2 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1534809 | norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System | PSN | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1536586 | Xulane 150/35 MCG/Day Weekly Transdermal System | PSN | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1536586 | 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System [Xulane] | SBD | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1534809 | 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System | SCD | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1534809 | ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch | SY | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1534809 | norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System | SY | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1536586 | Xulane (ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR) 7 Day Transdermal Patch | SY | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1536586 | Xulane 150/35 MCG/Day Weekly Transdermal System | SY | f7848550-086a-43d8-8ae5-047f4b9e4382 | 16 |
| 1534809 | norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System | PSN | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1536586 | Xulane 150/35 MCG/Day Weekly Transdermal System | PSN | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1536586 | 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System [Xulane] | SBD | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1534809 | 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System | SCD | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1534809 | ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch | SY | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1534809 | norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System | SY | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1536586 | Xulane (ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR) 7 Day Transdermal Patch | SY | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
| 1536586 | Xulane 150/35 MCG/Day Weekly Transdermal System | SY | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-3340-16 | 00378334016 | 7 d in 1 PATCH | 7 d | Historical | ||||
| 0378-3340-17 | 00378334017 | 1 in 1 POUCH | Historical | |||||
| 0378-3340-32 | 00378334032 | 1 POUCH in 1 CARTON (0378-3340-32) / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH | 1 pouch | 2016-06-13 | 0000-00-00 | Yes | No | Current |
| 0378-3340-53 | 00378334053 | 3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH | 3 pouch | 2014-04-16 | 0000-00-00 | No | No | Current |