Levothyroxine Sodium
- Product NDC
- 63323-647
- 11-digit product format
- 633230647
- Labeler code
- 63323
- Product ID
- 63323-647_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOTHYROXINE SODIUM ANHYDROUS
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA202231
- Marketing category
- NDA
- Marketing start
- 2011-06-24
- 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 |
|---|
| 63323-647-10 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 7 |
| 63323-647-10 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOTHYROXINE SODIUM ANHYDROUS | ACTIVE INGREDIENT | 054I36CPMN | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| LEVOTHYROXINE | ACTIVE MOIETY | Q51BO43MG4 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INACTIVE INGREDIENT | 70WT22SF4B | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-647 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250426_ce990712-49c1-4f66-9ee4-c770e8ec394c.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 |
|---|
| 63323-647-10 | 63323064710 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-647-10) / 5 mL in 1 VIAL, SINGLE-DOSE | 2011-06-24 | 0000-00-00 | No | No | Current |