Estradiol
- Product NDC
- 51862-333
- 11-digit product format
- 518620333
- Labeler code
- 51862
- Product ID
- 51862-333_82bf095a-96f7-49e1-9946-53eb3cad9989
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA040197
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- Marketing end
- 0000-00-00
- Substance
- ESTRADIOL
- Active strength
- 1 mg/1
- Pharmacologic classes
- Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-333-01 | EA - Each | 51862-333 | 43a0250a-53a9-449b-bd59-25d518b7d74a | 1 | 2016-09-02 |
| 51862-333-05 | EA - Each | 51862-333 | 0428318f-1957-4463-bfea-dc775451eb30 | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | ESTRADIOL TABLET [DIRECTRX] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 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 RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197658 | estradiol 1 MG Oral Tablet | PSN | b785a171-9d2d-425b-b812-0dddfbb4b71f | 5 |
| 197658 | estradiol 1 MG Oral Tablet | SCD | b785a171-9d2d-425b-b812-0dddfbb4b71f | 5 |
| 197658 | estradiol 1 MG Oral Tablet | PSN | bc186e19-74dd-f415-e053-2995a90a601b | 3 |
| 197659 | estradiol 2 MG Oral Tablet | PSN | bc186e19-74dd-f415-e053-2995a90a601b | 3 |
| 197658 | estradiol 1 MG Oral Tablet | SCD | bc186e19-74dd-f415-e053-2995a90a601b | 3 |
| 197659 | estradiol 2 MG Oral Tablet | SCD | bc186e19-74dd-f415-e053-2995a90a601b | 3 |
| 197658 | estradiol 1 MG Oral Tablet | PSN | 646c05cf-6a44-4281-bc1c-a77851b66fba | 1 |
| 197658 | estradiol 1 MG Oral Tablet | PSN | aa6c82b8-e214-2a07-e053-2a95a90ac737 | 1 |
| 197658 | estradiol 1 MG Oral Tablet | PSN | dead900f-baf5-2d2f-e053-2a95a90ac0a9 | 1 |
| 197658 | estradiol 1 MG Oral Tablet | SCD | 646c05cf-6a44-4281-bc1c-a77851b66fba | 1 |
| 197658 | estradiol 1 MG Oral Tablet | SCD | aa6c82b8-e214-2a07-e053-2a95a90ac737 | 1 |
| 197658 | estradiol 1 MG Oral Tablet | SCD | dead900f-baf5-2d2f-e053-2a95a90ac0a9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-333-01 | 51862033301 | 100 TABLET in 1 BOTTLE (51862-333-01) | 100 tablet | 2016-08-03 | 0000-00-00 | No | No | Current |
| 51862-333-05 | 51862033305 | 500 TABLET in 1 BOTTLE (51862-333-05) | 500 tablet | 2016-08-03 | 0000-00-00 | No | No | Current |