Junel FE
- Product NDC
- 72189-215
- 11-digit product format
- 721890215
- Labeler code
- 72189
- Product ID
- 72189-215_4d3a9c67-ae9a-d4c1-e063-6394a90aff1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Junel FE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA076380
- Marketing category
- ANDA
- Marketing start
- 2021-10-06
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 20; 1 ug/1; mg/1
- 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
- Junel FE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 20 ug/1 |
| NORETHINDRONE ACETATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1358762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-215-28 | Junel FE | 28 in 1 POUCH | TABLET | 28 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-215 | JUNEL FE TABLET [DIRECT_RX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250119_ea62a66e-d45d-11be-e053-2a95a90a7801.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 |
|---|
| 72189-215-28 | 72189021528 | 28 TABLET in 1 POUCH (72189-215-28) | 28 tablet | 2021-10-06 | 0000-00-00 | No | No | Current |