Prescription drug · ANDA
methimazole NDC 76483-082
Methimazole 5 mg/1 · Tablet · Oral · SQUARE PHARMACEUTICALS PLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76483-082-00 | 76483008200 | 100 TABLET in 1 BOTTLE (76483-082-00)Marketed from Dec 31, 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)
- methimazole
- Generic name (nonproprietary)
- methimazole
- Active ingredients
- Methimazole — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SQUARE PHARMACEUTICALS PLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218830
- Marketing start
- Listing expires
- Other FDA classes
- Thyroid Hormone Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 76483-082_3b305195-ceb2-495c-82c0-fa90bd5c1780SPL ID 3b305195-ceb2-495c-82c0-fa90bd5c1780SPL set ID 33e065a1-dd4e-43f9-a841-f96e633fc850RxCUI 197941, 197942UNII 554Z48XN5EUPC 0376483083008, 0376483082001
- Pharmacologic class
- Thyroid Hormone Synthesis Inhibitor
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
N476483008200followed by a unit qualifier and the quantityPackage 76483-0082-00. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218830
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 |
|---|---|---|---|---|
| methimazole | Methimazole 5 mg/1 | TabletOral | Coupler LLC | 67046-1651 |
| methimazole | Methimazole 10 mg/1 | TabletOral | Coupler LLC | 67046-1652 |
| methimazole | Methimazole 10 mg/1 | TabletOral | SQUARE PHARMACEUTICALS PLC. | 76483-083 |
| methimazole | Methimazole 5 mg/1 | TabletOral | Viona Pharmaceuticals Inc. | 72578-212 |
| methimazole | Methimazole 10 mg/1 | TabletOral | Viona Pharmaceuticals Inc. | 72578-213 |