EContra One-Step
- Product NDC
- 50102-211
- 11-digit product format
- 501020211
- Labeler code
- 50102
- Product ID
- 50102-211_d56023fd-6224-4727-bf3e-e5827dfe5f0a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Afaxys Pharma, LLC
- Application
- ANDA206867
- Marketing category
- ANDA
- Marketing start
- 2018-02-08
- Substance
- LEVONORGESTREL
- Active strength
- 1.5 mg/1
- Pharmacologic classes
- Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EContra One-Step
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVONORGESTREL | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5W7SIA7YZW |
| Rxcui | 483325, 1600602 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50102-211-01 | EContra One-Step | 1 in 1 BLISTER PACK | TABLET | 1 | | 11 |
| 50102-211-11 | EContra One-Step | 1 in 1 CARTON | TABLET | 1 | | 11 |
| 50102-211-13 | EContra One-Step | 3 in 1 PACKAGE | TABLET | 3 | | 11 |
| 50102-211-16 | EContra One-Step | 6 in 1 PACKAGE | TABLET | 6 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50102-211 | ECONTRA ONE-STEP (LEVONORGESTREL) TABLET [AFAXYS PHARMA, LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250410_94b23c49-dfba-4a70-ada5-e5c212e703c5.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 |
|---|
| 50102-211-01 | 50102021101 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50102-211-11 | 50102021111 | 1 in 1 CARTON | | | | | | Historical |
| 50102-211-13 | 50102021113 | 3 CARTON in 1 PACKAGE (50102-211-13) / 1 BLISTER PACK in 1 CARTON (50102-211-11) / 1 TABLET in 1 BLISTER PACK (50102-211-01) | 3 carton | 2020-10-27 | 0000-00-00 | No | No | Current |
| 50102-211-16 | 50102021116 | 6 CARTON in 1 PACKAGE (50102-211-16) > 1 BLISTER PACK in 1 CARTON (50102-211-11) > 1 TABLET in 1 BLISTER PACK (50102-211-01) | 6 carton | 2018-02-08 | 0000-00-00 | No | No | Current |