Estradiol Valerate
- Product NDC
- 0143-9291
- 11-digit product format
- 001439291
- Labeler code
- 0143
- Product ID
- 0143-9291_5fa9d3b5-6bfd-40e9-900e-21427f6c4d21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol Valerate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA203723
- Marketing category
- ANDA
- Marketing start
- 2020-04-21
- Substance
- ESTRADIOL VALERATE
- Active strength
- 40 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 | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OKG364O896 |
| Rxcui | 310189, 310190, 310191 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9291-01 | Estradiol Valerate | 5 mL in 1 VIAL | INJECTION | 5 | | 7 |
| 0143-9291-01 | Estradiol Valerate | 1 in 1 CARTON | INJECTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9291 | ESTRADIOL VALERATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240629_66f40ab0-4432-4e85-b709-a0bc076868c6.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 |
|---|
| 0143-9291-01 | 00143929101 | 1 VIAL in 1 CARTON (0143-9291-01) / 5 mL in 1 VIAL | 1 vial | 2020-04-21 | 0000-00-00 | No | No | Current |