ZAFEMY
- Product NDC
- 42291-930
- 11-digit product format
- 422910930
- Labeler code
- 42291
- Product ID
- 42291-930_48bfb94f-788f-40fe-e063-6294a90a3b86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norelgestromin and Ethinyl Estradiol
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- AvKARE
- Application
- ANDA213950
- Marketing category
- ANDA
- Marketing start
- 2023-05-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZAFEMY
- Listing expiration
- 2027-12-31
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, 2531285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-930-01 | ZAFEMY | 7 d in 1 PATCH | PATCH | 7 | | 2 |
| 42291-930-01 | ZAFEMY | 1 in 1 POUCH | PATCH | 1 | | 2 |
| 42291-930-03 | ZAFEMY | 3 in 1 CARTON | PATCH | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-930 | ZAFEMY (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [AVKARE] | 1 | Current NDC, 3 package rows | 20230516_fbbd12dd-c538-2869-e053-6294a90a1a38.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 |
|---|
| 42291-930-01 | 42291093001 | 7 d in 1 PATCH | 7 d | | | | Historical |
| 42291-930-03 | 42291093003 | 3 POUCH in 1 CARTON (42291-930-03) / 1 PATCH in 1 POUCH (42291-930-01) / 7 d in 1 PATCH | 3 pouch | 2023-05-15 | No | No | Current |