ELESTRIN
- Product NDC
- 0037-4801
- 11-digit product format
- 000374801
- Labeler code
- 0037
- Product ID
- 0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESTRADIOL
- Dosage form
- GEL, METERED
- Route
- TOPICAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA021813
- Marketing category
- NDA
- Marketing start
- 2014-06-02
- Substance
- ESTRADIOL
- Active strength
- .52 mg/.87g
- 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
- ELESTRIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .52 mg/.87g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 226597, 706467 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-4801-35 | ELESTRIN | 35 g in 1 BOTTLE, PUMP | GEL, METERED | 35 | | 18 |
| 0037-4801-70 | ELESTRIN | 2 in 1 CARTON | GEL, METERED | 2 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| DIETHYLENE GLYCOL MONOETHYL ETHER | INACTIVE INGREDIENT | A1A1I8X02B | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-4801 | ELESTRIN (ESTRADIOL) GEL, METERED [MEDA PHARMACEUTICALS INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240608_eff2dea1-f117-11e3-ac10-0800200c9a66.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 |
|---|
| 0037-4801-35 | 00037480135 | 35 g in 1 BOTTLE, PUMP | 35 g | | | | | Historical |
| 0037-4801-70 | 00037480170 | 2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35) | | 2018-11-05 | 0000-00-00 | No | No | Current |