Levothyroxine Sodium
- Product NDC
- 70511-113
- 11-digit product format
- 705110113
- Labeler code
- 70511
- Product ID
- 70511-113_9efa2867-7721-478a-a1c3-e34eeb3a1937
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOTHYROXINE SODIUM ANHYDROUS
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- MAIA Pharmaceuticals, Inc.
- Application
- ANDA208749
- Marketing category
- ANDA
- Marketing start
- 2018-12-27
- 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 |
|---|
| 70511-113-10 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 70511-113-10 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70511-113 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20190131_4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd.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 |
|---|
| 70511-113-10 | 70511011310 | 1 VIAL, SINGLE-USE in 1 CARTON (70511-113-10) / 5 mL in 1 VIAL, SINGLE-USE | 2018-12-27 | 0000-00-00 | No | No | Current |