BiEST 5.0 Estrogen Cream
- Product NDC
- 82018-0009
- 11-digit product format
- 820180009
- Labeler code
- 82018
- Product ID
- 82018-0009_37ca001c-de9a-f819-e063-6294a90a4c08
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- estriol,estradiol
- Dosage form
- CREAM
- Route
- TRANSDERMAL
- Labeler
- SHYNE BRANDS
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2025-06-01
- Substance
- ESTRADIOL; ESTRIOL
- Active strength
- 1; 4 mg/85g; mg/85g
- 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
- BiEST 5.0 Estrogen Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 1 mg/85g |
| ESTRIOL | 4 mg/85g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E, FB33469R8E |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82018-0009-3 | BiEST 5.0 Estrogen Cream | 85 g in 1 BOTTLE, PUMP | CREAM | 85 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82018-0009 | BIEST 5.0 ESTROGEN CREAM (ESTRIOL,ESTRADIOL) CREAM [SHYNE BRANDS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210622_c4d3860f-c211-b18c-e053-2a95a90a4474.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82018-0009-3 | 82018000903 | 85 g in 1 BOTTLE, PUMP (82018-0009-3) | 85 g | 2025-06-01 | 0000-00-00 | No | No | Current |