Prescription drug · ANDA
Levothyroxine Sodium (Levothyroxine sodium anhydrous) NDC 25021-468
Levothyroxine sodium anhydrous 100 ug/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-468-10 | 25021046810 | 1 VIAL in 1 CARTON (25021-468-10) / 5 mL in 1 VIALMarketed from Jan 1, 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)
- Levothyroxine Sodium
- Generic name (nonproprietary)
- levothyroxine sodium anhydrous
- Active ingredients
- Levothyroxine sodium anhydrous — 100 ug/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208749
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 25021-468_2662e418-ef9b-40be-abbd-db71401e3c20SPL ID 2662e418-ef9b-40be-abbd-db71401e3c20SPL set ID f57e9b19-6f17-4520-80fc-511322cc56c9RxCUI 966219, 1115267, 1115269UNII 054I36CPMN
- 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
N425021046810followed by a unit qualifier and the quantityPackage 25021-0468-10. 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.
About NDC 25021-468
- What is NDC 25021-468?
- 25021-468 is the product NDC for Levothyroxine Sodium (levothyroxine sodium anhydrous), Levothyroxine sodium anhydrous 100 ug/5mL injection, powder, lyophilized, for solution, listed with the FDA by Sagent Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levothyroxine Sodium (Levothyroxine Sodium Anhydrous).
- What is the active ingredient?
- Levothyroxine sodium anhydrous.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levothyroxine Sodium?
- 528 other product NDCs are listed under this name. See all Levothyroxine Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levothyroxine 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) |
|---|---|---|---|---|---|
| Levothyroxine Sodium | Levothyroxine sodium .05 mg/1 | TabletOral | Coupler LLC | 67046-0819 | 67046-0819-03 |
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | Coupler LLC | 67046-0972 | 67046-0972-03 |
| Levothyroxine Sodium | Levothyroxine sodium .2 mg/1 | TabletOral | Coupler LLC | 67046-0387 | 67046-0387-03 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | Coupler LLC | 67046-0951 | 67046-0951-03 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Coupler LLC | 67046-1679 | 67046-1679-03 |
| Levothyroxine Sodium | Levothyroxine sodium .175 mg/1 | TabletOral | Coupler LLC | 67046-0517 | 67046-0517-03 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | Coupler LLC | 67046-0569 | 67046-0569-03 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | Coupler LLC | 67046-0515 | 67046-0515-03 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Coupler LLC | 67046-0801 | 67046-0801-03 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Coupler LLC | 67046-0828 | 67046-0828-03 |
Other NDCs under ANDA 208749
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 | Sagent Pharmaceuticals | 25021-469 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 500 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-470 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 100 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | MAIA Pharmaceuticals, Inc. | 70511-111 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 200 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | MAIA Pharmaceuticals, Inc. | 70511-112 |
| Levothyroxine Sodiumlevothyroxine sodium anhydrous | Levothyroxine sodium anhydrous 500 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | MAIA Pharmaceuticals, Inc. | 70511-113 |