Prescription drug · ANDA
Methimazole NDC 72603-316
Methimazole 10 mg/1 · Tablet · Oral · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-316-01 | 72603031601 | 100 TABLET in 1 BOTTLE (72603-316-01)Marketed from Aug 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)
- Methimazole
- Generic name (nonproprietary)
- methimazole
- Active ingredients
- Methimazole — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NORTHSTAR RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040734
- Marketing start
- Listing expires
- Other FDA classes
- Thyroid Hormone Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 72603-316_d87b19ed-f2f6-41de-a5c0-167bfd2b319fSPL ID d87b19ed-f2f6-41de-a5c0-167bfd2b319fSPL set ID 923fec30-90fd-4bd5-beb3-f2ca4fc171eeRxCUI 197941, 197942UNII 554Z48XN5EUPC 0372603315011, 0372603316018
- 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
N472603031601followed by a unit qualifier and the quantityPackage 72603-0316-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Methimazole tablets are indicated: In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040734
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 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0883 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8347 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-315 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-380 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-381 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8226 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8227 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Proficient Rx LP | 82804-231 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6536 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1475 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1506 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-071 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-070 |