Estradiol and Norethindrone Acetate
- Product NDC
- 50742-657
- 11-digit product format
- 507420657
- Labeler code
- 50742
- Product ID
- 50742-657_e285b638-ef6a-40f1-9fc9-206dac35cb9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol and Norethindrone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA210612
- Marketing category
- ANDA
- Marketing start
- 2019-04-03
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 1; .5 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], 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
- Estradiol and Norethindrone Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 1 mg/1 |
| NORETHINDRONE ACETATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E, 9S44LIC7OJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50742-657-01 | Estradiol and Norethindrone Acetate | 28 in 1 BLISTER PACK | TABLET | 28 | | 4 |
| 50742-657-28 | Estradiol and Norethindrone Acetate | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 50742-657-68 | Estradiol and Norethindrone Acetate | 6 in 1 CARTON | TABLET | 6 | | 4 |
| 50742-657-84 | Estradiol and Norethindrone Acetate | 3 in 1 CARTON | TABLET | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-657 | ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240823_50c786d6-91bd-4eea-9455-ff2abc08372f.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 |
|---|
| 50742-657-01 | 50742065701 | 28 in 1 BLISTER PACK | | | | | | Historical |
| 50742-657-28 | 50742065728 | 1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK (50742-657-01) | 1 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |
| 50742-657-68 | 50742065768 | 6 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK (50742-657-01) | 6 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |
| 50742-657-84 | 50742065784 | 3 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACK (50742-657-01) | 3 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |