Lyleq
- Product NDC
- 50102-300
- 11-digit product format
- 501020300
- Labeler code
- 50102
- Product ID
- 50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NORETHINDRONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Afaxys Pharma, LLC
- Application
- ANDA207304
- Marketing category
- ANDA
- Marketing start
- 2016-09-23
- Substance
- NORETHINDRONE
- Active strength
- .35 mg/1
- Pharmacologic classes
- 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
- Lyleq
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORETHINDRONE | .35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T18F433X4S |
| Rxcui | 198042, 748961, 2397128 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50102-300-01 | Lyleq | 28 in 1 BLISTER PACK | TABLET | 28 | | 3 |
| 50102-300-11 | Lyleq | 1 in 1 PACKAGE | TABLET | 1 | | 3 |
| 50102-300-13 | Lyleq | 3 in 1 CARTON | TABLET | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50102-300 | LYLEQ (NORETHINDRONE) TABLET [AFAXYS PHARMA, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230401_c9f00a3e-c827-4066-bf85-079b3a20f25e.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 |
|---|
| 50102-300-01 | 50102030001 | 28 in 1 BLISTER PACK | | | | | | Historical |
| 50102-300-11 | 50102030011 | 1 in 1 PACKAGE | | | | | | Historical |
| 50102-300-13 | 50102030013 | 3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01) | 3 package | 2016-09-23 | 0000-00-00 | No | No | Current |