ESTRACE
- Product NDC
- 0430-3754
- 11-digit product format
- 004303754
- Labeler code
- 0430
- Product ID
- 0430-3754_4d3bc996-2273-415e-9fc1-158037932e15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Allergan, Inc.
- Application
- ANDA086069
- Marketing category
- ANDA
- Marketing start
- 2001-07-01
- Substance
- ESTRADIOL
- Active strength
- .1 mg/g
- 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
- ESTRACE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 310169, 890918 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0430-3754-14 | ESTRACE | 1 in 1 CARTON | CREAM | 1 | | 25 |
| 0430-3754-14 | ESTRACE | 36 in 1 CASE | CREAM | 36 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| CAPRYLIC/CAPRIC MONO/DIGLYCERIDES | INACTIVE INGREDIENT | U72Q2I8C85 | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| HYPROMELLOSE 2208 (4000 MPA.S) | INACTIVE INGREDIENT | 39J80LT57T | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| TERT-BUTYLHYDROQUINONE | INACTIVE INGREDIENT | C12674942B | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ESTRACE (ESTRADIOL) CREAM [WARNER CHILCOTT (US), LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0430-3754 | ESTRACE (ESTRADIOL) CREAM [ALLERGAN, INC.] | 25 | Current NDC, Legacy NDC, 2 package rows | 20241105_dfc41fcd-c5ba-4b25-b647-cf04d3988b3e.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 |
|---|
| 0430-3754-14 | 00430375414 | 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR | 36 carton | 2001-07-01 | 0000-00-00 | No | No | Current |