Prescription drug · NDA
Levothyroxine Sodium (levothyroxine sodium anhydrous) NDC 42023-202
Levothyroxine sodium anhydrous 200 ug/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · ENDO USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42023-202-01 | 42023020201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-202-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 24, 2011 |
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)
- Levothyroxine Sodium
- Generic name (nonproprietary)
- levothyroxine sodium anhydrous
- Active ingredients
- Levothyroxine sodium anhydrous — 200 ug/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- ENDO USA, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202231
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 42023-202_7e79776a-ca4b-49a9-8bc8-131c425c0bb2SPL ID 7e79776a-ca4b-49a9-8bc8-131c425c0bb2SPL set ID 9d815416-11c9-470e-a82f-89b0bf232e12RxCUI 966219, 1115267, 1115269UNII 054I36CPMNUPC 0342023201010, 0342023203014, 0342023202017
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N442023020201followed by a unit qualifier and the quantityPackage 42023-0202-01. 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)
Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (T 4 ) Sodium for Injection is indicated for the treatment of myxedema coma. ( 1 ) Important Limitations of Use: The relative bioavailability of this drug has not been established. Use caution when converting patients from o…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 202231
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 Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 200 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-647 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 500 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-648 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 500 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-648 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 100 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-649 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 100 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-649 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 100 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-649 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 100 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | ENDO USA, Inc. | 42023-201 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 500 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | ENDO USA, Inc. | 42023-203 |