Prescription drug · ANDA
Methimazole NDC 33342-336
Methimazole 10 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-336-11 | 3334203361133342033611 | 100 TABLET in 1 BOTTLE (33342-336-11)Marketed from May 24, 2023 | |
| 33342-336-12 | 3334203361233342033612 | 10 BLISTER PACK in 1 CARTON (33342-336-12) / 10 TABLET in 1 BLISTER PACKMarketed from May 24, 2023 | |
| 33342-336-44 | 3334203364433342033644 | 1000 TABLET in 1 BOTTLE (33342-336-44)Marketed from May 24, 2023 |
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
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209827
- Marketing start
- Listing expires
- Other FDA classes
- Thyroid Hormone Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-336_ea518c56-49d7-4770-8ded-21e443e71c3cSPL ID ea518c56-49d7-4770-8ded-21e443e71c3cSPL set ID 6f08df05-cc29-45ef-8f6e-12272bfbb0d7RxCUI 197941, 197942UNII 554Z48XN5EUPC 0333342335111, 0333342335449, 0333342336446, 0333342336118
- 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
N433342033611followed by a unit qualifier and the quantityPackage 33342-0336-11. 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 & USAGE Methimazole is 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.
About NDC 33342-336
- What is NDC 33342-336?
- 33342-336 is the product NDC for Methimazole, Methimazole 10 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methimazole.
- What is the active ingredient?
- Methimazole.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methimazole?
- 53 other product NDCs are listed under this name. See all Methimazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methimazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methimazole | Methimazole 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4747 | 70518-4747-00 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | AvKARE | 73190-084 | 73190-0084-01 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | AvKARE | 73190-085 | 73190-0085-01 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-011 | 11788-0011-0111788-0011-05 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-012 | 11788-0012-0111788-0012-05 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4063 | 68788-4063-0168788-4063-03 |
| methimazole | Methimazole 5 mg/1 | TabletOral | Coupler LLC | 67046-1651 | 67046-1651-03 |
| methimazole | Methimazole 10 mg/1 | TabletOral | Coupler LLC | 67046-1652 | 67046-1652-03 |
| Methimazole | Methimazole 5 mg/1 | TabletOral | AvPAK | 50268-495 | 50268-0495-15 |
| Methimazole | Methimazole 10 mg/1 | TabletOral | AvPAK | 50268-496 | 50268-0496-15 |
Other NDCs under ANDA 209827
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 | Macleods Pharmaceuticals Limited | 33342-335 |