ESTRADIOL
- Product NDC
- 68071-4485
- 11-digit product format
- 680714485
- Labeler code
- 68071
- Product ID
- 68071-4485_1a8d82ad-fcde-755b-e063-6394a90a3575
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESTRADIOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040275
- Marketing category
- ANDA
- Marketing start
- 2017-04-10
- Substance
- ESTRADIOL
- Active strength
- 2 mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 197659 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4485-1 | ESTRADIOL | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
| 68071-4485-3 | ESTRADIOL | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 68071-4485-6 | ESTRADIOL | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 68071-4485-9 | ESTRADIOL | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4485 | ESTRADIOL TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240612_7093dbe4-b096-2ddb-e053-2991aa0a1bb8.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 |
|---|
| 68071-4485-1 | 68071448501 | 120 TABLET in 1 BOTTLE (68071-4485-1) | 120 tablet | 2018-07-09 | No | No | Current |
| 68071-4485-3 | 68071448503 | 30 TABLET in 1 BOTTLE (68071-4485-3) | 30 tablet | 2018-07-09 | No | No | Current |
| 68071-4485-6 | 68071448506 | 60 TABLET in 1 BOTTLE (68071-4485-6) | 60 tablet | 2018-07-09 | No | No | Current |
| 68071-4485-9 | 68071448509 | 90 TABLET in 1 BOTTLE (68071-4485-9) | 90 tablet | 2018-07-09 | No | No | Current |