NDC codes

FDA NDC Directory
Product NDC (as listed)67253-651Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67253-0651Add 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
67253-651-1067253065110100 TABLET in 1 BOTTLE (67253-651-10)Marketed from Jul 28, 1947
67253-651-11672530651111000 TABLET in 1 BOTTLE (67253-651-11)Marketed from Jul 28, 1947

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
Par Health USA, LLCNDC labeler code 67253
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 006188
Marketing start
Listing expires
Other FDA classes
Thyroid Hormone Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 67253-651_7c284dbd-3508-48d1-86fd-3b50590e31e3SPL ID 7c284dbd-3508-48d1-86fd-3b50590e31e3SPL set ID b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0RxCUI 198175UNII 721M9407IYUPC 0367253651107, 0367253651114
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

N467253065110 followed by a unit qualifier and the quantity

Package 67253-0651-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Propylthiouracil is 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 67253-651

What is NDC 67253-651?
67253-651 is the product NDC for Propylthiouracil, Propylthiouracil 50 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 2 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?
Par Health USA, LLC, NDC labeler code 67253. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PropylthiouracilPropylthiouracil 50 mg/1TabletOralTeva Pharmaceuticals, Inc.0480-924200480-9242-01
PropylthiouracilPropylthiouracil 50 mg/1TabletOralMacleods Pharmaceuticals Limited33342-31433342-0314-1133342-0314-1233342-0314-44
PropylthiouracilPropylthiouracil 50 mg/1TabletOralQUAGEN PHARMACEUTICALS LLC70752-17170752-0171-1070752-0171-11
PropylthiouracilPropylthiouracil 50 mg/1TabletOralBryant Ranch Prepack71335-290171335-2901-01
PropylthiouracilPropylthiouracil 50 mg/1TabletOralBryant Ranch Prepack72162-207272162-2072-0172162-2072-02
PropylthiouracilPropylthiouracil 50 mg/1TabletOralAmerican Health Packaging68084-96468084-0964-25
PropylthiouracilPropylthiouracil 50 mg/1TabletOralChartwell RX, LLC62135-60662135-0606-90

Other NDCs under NDA 006188

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

FDA NDC Directory listings under NDA 006188
ProductStrengthForm · routeLabelerProduct NDC
PropylthiouracilPropylthiouracil 50 mg/1TabletOralAmerican Health Packaging68084-964

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