Prescription drug · NDA
Levoxyl (Levothyroxine sodium) NDC 60793-855
Levothyroxine sodium 112 ug/1 · Tablet · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60793-855-01 | 60793085501 | 100 TABLET in 1 BOTTLE (60793-855-01)Marketed from May 25, 2001 | |
| 60793-855-10 | 60793085510 | 1000 TABLET in 1 BOTTLE (60793-855-10)Marketed from May 25, 2001 |
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)
- Levoxyl
- Generic name (nonproprietary)
- levothyroxine sodium
- Active ingredients
- Levothyroxine sodium — 112 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 60793
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021301
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 60793-855_e230c170-2a16-47d0-bce7-ac0414c192f7SPL ID e230c170-2a16-47d0-bce7-ac0414c192f7SPL set ID 758588c3-c63e-491b-0aa2-4f50d80cb174RxCUI 892246, 892251, 966157, 966164, 966170, 966175, 966184, 966190, 966194, 966200, 966204, 966211, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270, 966283UNII 9J765S329GUPC 0360793856018, 0360793850016, 0360793852010, 0360793851013, 0360793857015, 0360793853017, 0360793854014, 0360793858012, 0360793855011, 0360793859019, 0360793860015
- 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
N460793085501followed by a unit qualifier and the quantityPackage 60793-0855-01. 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)
LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement 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 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 hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism LEVOXYL is indicated in pedi…
Excerpt only. Read the full label for complete information.
About NDC 60793-855
- What is NDC 60793-855?
- 60793-855 is the product NDC for Levoxyl (levothyroxine sodium), Levothyroxine sodium 112 ug/1 tablet, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levoxyl (Levothyroxine sodium).
- What is the active ingredient?
- Levothyroxine sodium.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 60793. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levoxyl?
- 10 other product NDCs are listed under this name. See all Levoxyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levoxyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levoxyllevothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-850 | 60793-0850-0160793-0850-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-851 | 60793-0851-0160793-0851-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-852 | 60793-0852-0160793-0852-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-853 | 60793-0853-0160793-0853-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-854 | 60793-0854-0160793-0854-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-856 | 60793-0856-0160793-0856-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-857 | 60793-0857-0160793-0857-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-858 | 60793-0858-0160793-0858-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-859 | 60793-0859-0160793-0859-10 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-860 | 60793-0860-0160793-0860-10 |
Other NDCs under NDA 021301
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 |
|---|---|---|---|---|
| Levoxyllevothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-850 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-851 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-852 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-853 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-854 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-856 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-857 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-858 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-859 |
| Levoxyllevothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 60793-860 |