norelgestromin and ethinyl estradiol
- Product NDC
- 70710-1190
- 11-digit product format
- 707101190
- Labeler code
- 70710
- Product ID
- 70710-1190_404277f1-4343-462c-b508-10c22dc7bc2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norelgestromin and ethinyl estradiol
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA214594
- Marketing category
- ANDA
- Marketing start
- 2023-11-21
- Substance
- ETHINYL ESTRADIOL; NORELGESTROMIN
- Active strength
- 35; 150 ug/mg; ug/mg
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- norelgestromin and ethinyl estradiol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 35 ug/mg |
| NORELGESTROMIN | 150 ug/mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, R0TAY3X631 |
| Rxcui | 1534809 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1190-1 | norelgestromin and ethinyl estradiol | 7 mg in 1 POUCH | PATCH | 7 | | 3 |
| 70710-1190-1 | norelgestromin and ethinyl estradiol | 1 in 1 POUCH | PATCH | 1 | | 3 |
| 70710-1190-3 | norelgestromin and ethinyl estradiol | 3 in 1 CARTON | PATCH | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1190 | NORELGESTROMIN AND ETHINYL ESTRADIOL PATCH [ZYDUS PHARMACEUTICALS USA INC.] | 2 | Current NDC, 3 package rows | 20241130_10fa1458-c8ed-4197-922a-1ba7271d2b02.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1190-1 | 70710119001 | 7 mg in 1 POUCH | 7 mg | | | | Historical |
| 70710-1190-3 | 70710119003 | 3 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCH | 3 pouch | 2023-11-21 | No | No | Current |