Levothyroxine Sodium
- Product NDC
- 83270-007
- 11-digit product format
- 832700007
- Labeler code
- 83270
- Product ID
- 83270-007_35b79b8a-71ee-374b-e063-6394a90a887a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOTHYROXINE SODIUM ANHYDROUS
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ONESOURCE SPECIALTY PHARMA LIMITED
- Application
- ANDA216729
- Marketing category
- ANDA
- Marketing start
- 2025-08-15
- Substance
- LEVOTHYROXINE SODIUM ANHYDROUS
- Active strength
- 200 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 | 200 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 |
|---|
| 83270-007-01 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 83270-007-01 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83270-007-01 | 83270000701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83270-007-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2025-09-30 | No | No | Current |