Prescription drug · NDA
Propylthiouracil NDC 67253-651
Propylthiouracil 50 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67253-651-10 | 67253065110 | 100 TABLET in 1 BOTTLE (67253-651-10)Marketed from Jul 28, 1947 | |
| 67253-651-11 | 67253065111 | 1000 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
N467253065110followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Propylthiouracil products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Macleods Pharmaceuticals Limited | 33342-314 | 33342-0314-1133342-0314-1233342-0314-44 |
| 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 |
Other NDCs under NDA 006188
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Propylthiouracil | Propylthiouracil 50 mg/1 | TabletOral | American Health Packaging | 68084-964 |