NDC 0378-1815-01 - Levothyroxine Sodium
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0378-1815
- Requested NDC
- 0378-1815-01
- Package NDCs from labels
- 0378-1815-77, 0378-1815-10, 0378-1815-01
- Manufacturer
- Mylan Institutional Inc.
- Effective date
- 2025-07-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Levothyroxine Sodium - Mylan Institutional Inc. | Mylan Institutional Inc. | 2025-07-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Levothyroxine Sodium - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2024-04-15 | HUMAN PRESCRIPTION DRUG LABEL |
| Levothyroxine Sodium - State of Florida DOH Central Pharmacy | State of Florida DOH Central Pharmacy | 2014-10-21 | HUMAN PRESCRIPTION DRUG LABEL |
| LEVOTHYROXINE SODIUM - Physicians Total Care, Inc. | Physicians Total Care, Inc. | 2011-03-23 | HUMAN PRESCRIPTION DRUG LABEL |
| Levothyroxine Sodium - State of Florida DOH Central Pharmacy | State of Florida DOH Central Pharmacy | 2010-08-19 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-1815-10 | Levothyroxine Sodium | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 31 | |
| 0378-1815-77 | Levothyroxine Sodium | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 31 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-1815-01 | EA - Each | 0378-1815 | ac8debd6-80c2-4b03-9e97-e6968dd9bf3a | 1 | 2012-07-24 |
| 0378-1815-04 | EA - Each | 0378-1815 | 61914b43-e646-4263-9242-9e2c71061938 | 1 | 2020-09-14 |
| 0378-1815-10 | EA - Each | 0378-1815 | 8b4b946c-655b-436d-aba1-735a19038cfc | 1 | 2012-07-24 |
| 0378-1815-77 | EA - Each | 0378-1815 | bc8d7bc4-0341-4f36-a2f1-eb83b35a781b | 1 | 2016-07-19 |
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | abe173cc-1579-43a5-b12d-a31958d0a539 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 966248 966222 966270 892246 966221 966224 966249 966220 966225 966253 9J765S329G |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Cardinal Health 107, LLC | 66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | ANDA076187 966222 892246 966221 966224 966220 966225 9J765S329G |
| BM Silicea Icing Sugar | SILICEA ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 535ba100-627f-36b4-e063-6394a90a3373 | 2026-06-03 | Warnings | ETJ7Z6XBU4 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 53316e75-9897-4935-e063-6294a90a94cf | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 966249 9J765S329G |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | BM Private Limited | 5331dc40-2ac8-5fce-e063-6394a90a5875 | 2026-06-01 | Warnings | ETJ7Z6XBU4 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 5852d874-1ebc-49ff-b6c2-1dd513fca784 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 966222 9J765S329G |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | c8ae9dc4-836f-4912-80d7-684fd374f40a | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 966221 9J765S329G |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 52cce695-4363-8a2c-e063-6294a90a1bbf | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 892246 9J765S329G |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 52cd19e4-a4b3-ecee-e063-6394a90ac33b | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 966225 9J765S329G |
| Ripple | GLYCERIN, POVIDONE | CorneaCare Inc | 3b5ba197-d501-681e-e063-6294a90aefb5 | 2026-05-24 | Warnings | FZ989GH94E |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | db5cba81-9ad5-42ad-ac9e-a967337630f2 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 966270 9J765S329G |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d9ccea69-109d-44cf-927b-4ff67652b6a0 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 966249 9J765S329G |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 4f40db1e-3dd9-4c7b-93e6-64f0fd10d551 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 966225 9J765S329G |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 50978a14-fd72-4c76-927f-667a1f097b87 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 966248 9J765S329G |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | eb53dc23-8337-497e-b466-192f905563ed | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 892251 9J765S329G |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 6d65b528-f52b-4b5d-8b76-46fbd4576f99 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 966270 9J765S329G |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 3519c765-2077-4f23-8644-a6242ddbf743 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 966249 9J765S329G |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | c38c3c31-6834-4590-ace0-f525e5599f66 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 966222 9J765S329G |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | ac10b751-5195-4987-a841-400ae79730f0 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 966222 9J765S329G |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 83854522-f22e-491f-8392-c8b1f9441760 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 966248 966224 966253 9J765S329G |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.