NDC codes

FDA NDC Directory
Product NDC (as listed)68084-964Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0964Add 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
68084-964-256808409642530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-964-25) / 1 TABLET in 1 BLISTER PACK (68084-964-95)Marketed from Oct 8, 2015

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
American Health PackagingNDC labeler code 68084
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 68084-964_5a08b89c-d38c-ccd7-e063-6394a90aaba1SPL ID 5a08b89c-d38c-ccd7-e063-6394a90aaba1SPL set ID d819e532-09ac-434a-84a6-636c4204c7aaRxCUI 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

N468084096425 followed by a unit qualifier and the quantity

Package 68084-0964-25. 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 68084-964

What is NDC 68084-964?
68084-964 is the product NDC for Propylthiouracil, Propylthiouracil 50 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?
American Health Packaging, NDC labeler code 68084. 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/1TabletOralChartwell RX, LLC62135-60662135-0606-90
PropylthiouracilPropylthiouracil 50 mg/1TabletOralPar Health USA, LLC67253-65167253-0651-1067253-0651-11

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/1TabletOralPar Health USA, LLC67253-651

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