Norelgestromin and Ethinly Estradiol
- Product NDC
- 69238-1521
- 11-digit product format
- 692381521
- Labeler code
- 69238
- Product ID
- 69238-1521_0a63a330-c4d1-4fb0-8e11-10b2971f1a57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norelgestromin and Ethinly Estradiol
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA213950
- Marketing category
- ANDA
- Marketing start
- 2021-02-26
- 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
- Norelgestromin and Ethinly Estradiol
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1521-1 | Norelgestromin and Ethinly Estradiol | 7 d in 1 PATCH | PATCH | 7 | | 9 |
| 69238-1521-1 | Norelgestromin and Ethinly Estradiol | 1 in 1 POUCH | PATCH | 1 | | 9 |
| 69238-1521-3 | Norelgestromin and Ethinly Estradiol | 3 in 1 CARTON | PATCH | 3 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1521 | NORELGESTROMIN AND ETHINLY ESTRADIOL PATCH [AMNEAL PHARMACEUTICALS NY LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20231231_36445b6a-e0f2-42f7-a8f3-5b80c90b87dd.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 |
|---|
| 69238-1521-1 | 69238152101 | 7 d in 1 PATCH | 7 d | | | | | Historical |
| 69238-1521-3 | 69238152103 | 3 POUCH in 1 CARTON (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH | 3 pouch | 2021-02-26 | 0000-00-00 | No | No | Current |