Prescription drug · ANDA
Liothyronine sodium NDC 70377-115
Liothyronine sodium 25 ug/1 · Tablet · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-115-11 | 70377011511 | 90 TABLET in 1 BOTTLE (70377-115-11)Marketed from Feb 12, 2024 | |
| 70377-115-12 | 70377011512 | 100 TABLET in 1 BOTTLE (70377-115-12)Marketed from Feb 12, 2024 | |
| 70377-115-13 | 70377011513 | 1000 TABLET in 1 BOTTLE (70377-115-13)Marketed from Feb 12, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Liothyronine sodium
- Generic name (nonproprietary)
- liothyronine sodium
- Active ingredients
- Liothyronine sodium — 25 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Biocon Pharma Inc.NDC labeler code 70377
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218070
- Marketing start
- Listing expires
- Other FDA classes
- Triiodothyronine (Chemical structure)
- Identifiers
- Product ID 70377-115_c2af2408-91ba-b0c3-349f-20ca285e0fc9SPL ID c2af2408-91ba-b0c3-349f-20ca285e0fc9SPL set ID 21002702-422b-1402-73b8-670314d8e579RxCUI 903456, 903697, 903703UNII GCA9VV7D2NUPC 0370377115110, 0370377116117, 0370377114113
- Pharmacologic class
- l-Triiodothyronine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470377011511followed by a unit qualifier and the quantityPackage 70377-0115-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Liothyronine is an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatm…
Excerpt only. Read the full label for complete information.
About NDC 70377-115
- What is NDC 70377-115?
- 70377-115 is the product NDC for Liothyronine sodium, Liothyronine sodium 25 ug/1 tablet, listed with the FDA by Biocon Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Liothyronine sodium.
- What is the active ingredient?
- Liothyronine sodium.
- Who is the labeler?
- Biocon Pharma Inc., NDC labeler code 70377. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Liothyronine sodium?
- 44 other product NDCs are listed under this name. See all Liothyronine sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Liothyronine sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Liothyronine Sodium | Liothyronine sodium 50 ug/1 | TabletOral | Dr. Reddy's Labratories Inc. | 75907-004 | 75907-0004-01 |
| Liothyronine Sodium | Liothyronine sodium 25 ug/1 | TabletOral | Dr. Reddy's Labratories Inc. | 75907-001 | 75907-0001-01 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | Dr. Reddy's Labratories Inc. | 75907-039 | 75907-0039-01 |
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | Biocon Pharma Inc. | 70377-114 | 70377-0114-1170377-0114-1270377-0114-13 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Biocon Pharma Inc. | 70377-116 | 70377-0116-1170377-0116-1270377-0116-13 |
| Liothyronine sodium | Liothyronine sodium 25 ug/1 | TabletOral | Northstar Rx LLC | 16714-167 | 16714-0167-01 |
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | Northstar Rx LLC | 16714-166 | 16714-0166-01 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Northstar Rx LLC | 16714-168 | 16714-0168-01 |
| Liothyronine Sodium | Liothyronine sodium 25 ug/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2178 | 00093-2178-01 |
| Liothyronine Sodium | Liothyronine sodium 50 ug/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2180 | 00093-2180-01 |
Other NDCs under ANDA 218070
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | Biocon Pharma Inc. | 70377-114 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Biocon Pharma Inc. | 70377-116 |