What is NDC 33342-314?

33342-314 is the product NDC for Propylthiouracil, Propylthiouracil 50 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 Propylthiouracil?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Propylthiouracil NDC 33342-314 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-314Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0314Add 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
33342-314-11	33342031411	100 TABLET in 1 BOTTLE (33342-314-11)Marketed from May 10, 2023
33342-314-12	33342031412	10 BLISTER PACK in 1 CARTON (33342-314-12) / 10 TABLET in 1 BLISTER PACKMarketed from May 10, 2023
33342-314-44	33342031444	1000 TABLET in 1 BOTTLE (33342-314-44)Marketed from May 10, 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): Propylthiouracil
Generic name (nonproprietary): propylthiouracil
Active ingredients: Propylthiouracil — 50 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 208867
Marketing start: May 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Thyroid Hormone Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 33342-314_7e848dc9-0f07-4dd1-8aa6-a64558a1ddb8SPL ID 7e848dc9-0f07-4dd1-8aa6-a64558a1ddb8SPL set ID a251e4cb-01f1-4fd8-bd30-362126b85073RxCUI 198175UNII 721M9407IY
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

N433342031411 followed by a unit qualifier and the quantity

Package 33342-0314-11. 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 Sep 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Propylthiouracil are indicated: • in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and 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 in patients who are intolerant of methimazole

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-314

What is NDC 33342-314?: 33342-314 is the product NDC for Propylthiouracil, Propylthiouracil 50 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?: Propylthiouracil.
What is the active ingredient?: Propylthiouracil.
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 Propylthiouracil?: 7 other product NDCs are listed under this name. See all Propylthiouracil 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 Propylthiouracil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	Teva Pharmaceuticals, Inc.	0480-9242	00480-9242-01
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	QUAGEN PHARMACEUTICALS LLC	70752-171	70752-0171-1070752-0171-11
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2901	71335-2901-01
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	Bryant Ranch Prepack	72162-2072	72162-2072-0172162-2072-02
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	American Health Packaging	68084-964	68084-0964-25
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	Chartwell RX, LLC	62135-606	62135-0606-90
Propylthiouracil	Propylthiouracil 50 mg/1	TabletOral	Par Health USA, LLC	67253-651	67253-0651-1067253-0651-11