NDC codes

FDA NDC Directory
Product NDC (as listed)33342-336Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0336Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
33342-336-113334203361133342033611100 TABLET in 1 BOTTLE (33342-336-11)Marketed from May 24, 2023
33342-336-12333420336123334203361210 BLISTER PACK in 1 CARTON (33342-336-12) / 10 TABLET in 1 BLISTER PACKMarketed from May 24, 2023
33342-336-4433342033644333420336441000 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

N433342033611 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methimazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MethimazoleMethimazole 5 mg/1TabletOralREMEDYREPACK INC.70518-474770518-4747-00
MethimazoleMethimazole 5 mg/1TabletOralAvKARE73190-08473190-0084-01
MethimazoleMethimazole 10 mg/1TabletOralAvKARE73190-08573190-0085-01
MethimazoleMethimazole 5 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-01111788-0011-0111788-0011-05
MethimazoleMethimazole 10 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-01211788-0012-0111788-0012-05
MethimazoleMethimazole 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-406368788-4063-0168788-4063-03
methimazoleMethimazole 5 mg/1TabletOralCoupler LLC67046-165167046-1651-03
methimazoleMethimazole 10 mg/1TabletOralCoupler LLC67046-165267046-1652-03
MethimazoleMethimazole 5 mg/1TabletOralAvPAK50268-49550268-0495-15
MethimazoleMethimazole 10 mg/1TabletOralAvPAK50268-49650268-0496-15

All 54 Methimazole NDCs

Other NDCs under ANDA 209827

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209827
ProductStrengthForm · routeLabelerProduct NDC
MethimazoleMethimazole 5 mg/1TabletOralMacleods Pharmaceuticals Limited33342-335

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