ESTRADIOL VALERATE
- Product NDC
- 0517-0420
- 11-digit product format
- 005170420
- Labeler code
- 0517
- Product ID
- 0517-0420_abfdb011-4fe4-4c0f-b2df-77398b47738f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESTRADIOL VALERATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- American Regent, Inc.
- Application
- ANDA090920
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Substance
- ESTRADIOL VALERATE
- Active strength
- 20 mg/mL
- 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
- ESTRADIOL VALERATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL VALERATE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OKG364O896 |
| Rxcui | 310190, 310191 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-0420-01 | ESTRADIOL VALERATE | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 5 |
| 0517-0420-01 | ESTRADIOL VALERATE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0420 | ESTRADIOL VALERATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241030_2984bce2-89bf-4768-a1ca-ccf03b1197be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0517-0420-01 | 00517042001 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2020-03-01 | 0000-00-00 | No | No | Current |