Estradiol
- Product NDC
- 0555-0899
- 11-digit product format
- 005550899
- Labeler code
- 0555
- Product ID
- 0555-0899_e9b2e697-6e57-436a-933d-5554ca402da7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA040197
- Marketing category
- ANDA
- Marketing start
- 1997-10-28
- Substance
- ESTRADIOL
- Active strength
- .5 mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Estradiol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 197657, 197658, 197659 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0555-0899-02 | Estradiol | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESTRADIOL TABLET [BARR LABORATORIES INC.] | 4 | |
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESTRADIOL TABLET [DIRECTRX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0555-0899 | ESTRADIOL TABLET [TEVA PHARMACEUTICALS USA, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240308_c4936878-1643-4e7f-9b0d-e4957935aef2.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 |
|---|
| 0555-0899-02 | 00555089902 | 100 TABLET in 1 BOTTLE (0555-0899-02) | 100 tablet | 1997-10-28 | 0000-00-00 | No | No | Current |