Estrace
- Product NDC
- 0430-0721
- 11-digit product format
- 004300721
- Labeler code
- 0430
- Product ID
- 0430-0721_7d28252e-6605-4939-8d94-b2287d66fd98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Allergan, Inc.
- Application
- ANDA040197
- Marketing category
- ANDA
- Marketing start
- 2011-12-26
- 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0430-0721 | ESTRACE (ESTRADIOL) TABLET [ALLERGAN, INC.] | 12 | Legacy NDC | 20240418_a3803ba3-4eee-4e2e-ac8c-821a4e6720cc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0430-0721-24 | 00430072124 | 100 TABLET in 1 BOTTLE (0430-0721-24) | 100 tablet | 2011-12-26 | 0000-00-00 | No | No | Current |