Levothyroxine Sodium
- Product NDC
- 42023-203
- 11-digit product format
- 420230203
- Labeler code
- 42023
- Product ID
- 42023-203_7e79776a-ca4b-49a9-8bc8-131c425c0bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOTHYROXINE SODIUM ANHYDROUS
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ENDO USA, Inc.
- Application
- NDA202231
- Marketing category
- NDA
- Marketing start
- 2011-06-24
- Substance
- LEVOTHYROXINE SODIUM ANHYDROUS
- Active strength
- 500 ug/5mL
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levothyroxine Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM ANHYDROUS | 500 ug/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 054I36CPMN |
| Rxcui | 966219, 1115267, 1115269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42023-203-01 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 42023-203-01 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-203 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250509_9d815416-11c9-470e-a82f-89b0bf232e12.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 |
|---|
| 42023-203-01 | 42023020301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-203-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2011-06-24 | 0000-00-00 | No | No | Current |