Levothyroxine Sodium
- Product NDC
- 63323-885
- 11-digit product format
- 633230885
- Labeler code
- 63323
- Product ID
- 63323-885_09cdd46f-eae9-4faa-b3b3-67fcd71b62ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA210632
- Marketing category
- NDA
- Marketing start
- 2018-05-29
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 20 ug/mL
- 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 | 20 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 2166148, 2166193, 2166196 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-885-10 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 4 |
| 63323-885-10 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 63323-885-12 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 1 |
| 63323-885-12 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 63323-885-14 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 1 |
| 63323-885-14 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-885 | LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250419_08f4b1f8-6807-47e7-bef8-8d1972aa0557.zip |
| 63323-885 | LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20201210_50b1c8a4-75b6-49c8-80fc-3841ee80b183.zip |
| 63323-885 | LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20201210_388a1f15-8c1c-46a5-997f-7f326f696b59.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 |
|---|
| 63323-885-10 | 63323088510 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-10) / 5 mL in 1 VIAL, SINGLE-DOSE | 2018-05-29 | 0000-00-00 | No | No | Current |
| 63323-885-12 | 63323088512 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-12) / 5 mL in 1 VIAL, SINGLE-DOSE | 2018-05-29 | 0000-00-00 | No | No | Current |
| 63323-885-14 | 63323088514 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-14) / 5 mL in 1 VIAL, SINGLE-DOSE | 2018-05-29 | 0000-00-00 | No | No | Current |