ESTRADIOL
- Product NDC
- 68071-3394
- 11-digit product format
- 680713394
- Labeler code
- 68071
- Product ID
- 68071-3394_1d7a3223-4396-0d18-e063-6394a90a9927
- 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
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 197658 |
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 |
|---|
| 68071-3394-2 | ESTRADIOL | 120 in 1 BOTTLE | TABLET | 120 | | 6 |
| 68071-3394-3 | ESTRADIOL | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 68071-3394-6 | ESTRADIOL | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 68071-3394-9 | ESTRADIOL | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3394 | ESTRADIOL TABLET [NUCARE PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240719_5423c0da-eb10-20cd-e054-00144ff8d46c.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 |
|---|
| 68071-3394-2 | 68071339402 | 120 TABLET in 1 BOTTLE (68071-3394-2) | 120 tablet | 2017-07-12 | 0000-00-00 | No | No | Current |
| 68071-3394-3 | 68071339403 | 30 TABLET in 1 BOTTLE (68071-3394-3) | 30 tablet | 2017-07-12 | 0000-00-00 | No | No | Current |
| 68071-3394-6 | 68071339406 | 60 TABLET in 1 BOTTLE (68071-3394-6) | 60 tablet | 2017-07-12 | 0000-00-00 | No | No | Current |
| 68071-3394-9 | 68071339409 | 90 TABLET in 1 BOTTLE (68071-3394-9) | 90 tablet | 2017-07-12 | 0000-00-00 | No | No | Current |