Prescription drug · NDA AUTHORIZED GENERIC
Levothyroxine Sodium NDC 82347-0035
Levothyroxine sodium 112 ug/1 · Capsule · Oral · YARAL Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82347-0035-4 | 82347003504 | 3 BLISTER PACK in 1 CARTON (82347-0035-4) / 10 CAPSULE in 1 BLISTER PACKMarketed from Mar 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Levothyroxine Sodium
- Generic name (nonproprietary)
- levothyroxine sodium
- Active ingredients
- Levothyroxine sodium — 112 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- YARAL Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021924
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 82347-0035_4dde84bb-3bd3-6722-e063-6394a90a4c09SPL ID 4dde84bb-3bd3-6722-e063-6394a90a4c09SPL set ID d28d7202-1278-0486-e053-2995a90af286RxCUI 905451, 905455, 905458, 905462, 966404, 966405, 966406, 966407, 966412, 966413, 1923047, 1923050UNII 9J765S329GUPC 0382347000548, 0382347003549, 0382347005543, 0382347004546, 0382347001040, 0382347006045, 0382347001545, 0382347005048, 0382347002542, 0382347002047, 0382347004041, 0382347003044
- Pharmacologic class
- l-Thyroxine
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
N482347003504followed by a unit qualifier and the quantityPackage 82347-0035-04. 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)
1 INDICATION AND USAGE Levothyroxine Sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021924
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 |
|---|---|---|---|---|
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0015 |
| Levothyroxine Sodium | Levothyroxine sodium 13 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0005 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0010 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0030 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0020 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0025 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0050 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0040 |
| Levothyroxine Sodium | Levothyroxine sodium 137 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0045 |
| Levothyroxine Sodium | Levothyroxine sodium 175 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0055 |
| Levothyroxine Sodium | Levothyroxine sodium 200 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0060 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 37.5 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0012 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 13 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0005 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0010 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 62.5 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0017 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 44 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0013 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0015 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 112 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0035 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 75 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0020 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 88 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0025 |
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