What is NDC 50268-495?

50268-495 is the product NDC for Methimazole, Methimazole 5 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methimazole NDC 50268-495 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-495Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0495Add 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 NDC	11-digit (billing)	Package	Copy
50268-495-15	5026804951550268049515	50 BLISTER PACK in 1 BOX (50268-495-15) / 1 TABLET in 1 BLISTER PACK (50268-495-11)Marketed from Oct 13, 2025

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: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218149
Marketing start: Oct 13, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Thyroid Hormone Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 50268-495_41168239-a16a-40e0-e063-6294a90a5c58SPL ID 41168239-a16a-40e0-e063-6294a90a5c58SPL set ID 4116774b-6c2b-2c74-e063-6394a90a4955RxCUI 197941, 197942UNII 554Z48XN5E
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

N450268049515 followed by a unit qualifier and the quantity

Package 50268-0495-15. 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 Oct 13, 2025.

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.

Full label on DailyMed (opens in a new tab)

About NDC 50268-495

What is NDC 50268-495?: 50268-495 is the product NDC for Methimazole, Methimazole 5 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, 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?: AvPAK, NDC labeler code 50268. 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
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 10 mg/1	TabletOral	AvPAK	50268-496	50268-0496-15
methimazole	Methimazole 5 mg/1	TabletOral	Viona Pharmaceuticals Inc.	72578-212	72578-0212-01

All 54 Methimazole NDCs

Other NDCs under ANDA 218149

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

FDA NDC Directory listings under ANDA 218149
Product	Strength	Form · route	Labeler	Product NDC
Methimazole	Methimazole 10 mg/1	TabletOral	AvPAK	50268-496
Methimazole	Methimazole 5 mg/1	TabletOral	Bionpharma Inc.	69452-328
Methimazole	Methimazole 10 mg/1	TabletOral	Bionpharma Inc.	69452-329