Levothyroxine sodium
- Product NDC
- 71205-646
- 11-digit product format
- 712050646
- Labeler code
- 71205
- Product ID
- 71205-646_d0d8a699-8d2a-469a-b19b-a75ebd1d46f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212399
- Marketing category
- ANDA
- Marketing start
- 2020-11-25
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 50 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71205-646_d0d8a699-8d2a-469a-b19b-a75ebd1d46f1
- SPL ID
- d0d8a699-8d2a-469a-b19b-a75ebd1d46f1
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Levothyroxine sodium
- Generic name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2020-11-25
- Marketing category
- ANDA
- Application number
- ANDA212399
- Pharmacologic classes
- Thyroxine [CS]; l-Thyroxine [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM | 50 ug/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 966221 |
| Spl Set Id | 329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71205-646-30 | 30 TABLET in 1 BOTTLE (71205-646-30) | 2022-03-22 | No |
| 71205-646-60 | 60 TABLET in 1 BOTTLE (71205-646-60) | 2022-03-22 | No |
| 71205-646-90 | 90 TABLET in 1 BOTTLE (71205-646-90) | 2022-03-22 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9J765S329G | LEVOTHYROXINE SODIUM | 6106-07-6 | LEVOTHYROXINE SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-646-30 | 71205064630 | 30 TABLET in 1 BOTTLE (71205-646-30) | 30 tablet | 2022-03-22 | No | No | Historical |
| 71205-646-60 | 71205064660 | 60 TABLET in 1 BOTTLE (71205-646-60) | 60 tablet | 2022-03-22 | No | No | Historical |
| 71205-646-90 | 71205064690 | 90 TABLET in 1 BOTTLE (71205-646-90) | 90 tablet | 2022-03-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Levothyroxine sodium | Proficient Rx LP | 2022-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |