Prescription drug · ANDA
Methimazole NDC 64980-264
Methimazole 5 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-264-01 | 64980026401 | 100 TABLET in 1 BOTTLE (64980-264-01)Marketed from Apr 22, 2021 |
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
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202068
- Marketing start
- Listing expires
- Other FDA classes
- Thyroid Hormone Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 64980-264_2ac7fbad-6a1b-4326-9339-b2b3139ce554SPL ID 2ac7fbad-6a1b-4326-9339-b2b3139ce554SPL set ID 289ec852-176e-41aa-9f9a-b1f9b4196771RxCUI 197941, 197942UNII 554Z48XN5EUPC 0364980265010
- 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
N464980026401followed by a unit qualifier and the quantityPackage 64980-0264-01. 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 202068
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 | Preferred Pharmaceuticals Inc. | 68788-8883 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4063 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2218 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-265 |