Prescription drug · ANDA
Propylthiouracil NDC 70752-171
Propylthiouracil 50 mg/1 · Tablet · Oral · QUAGEN PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70752-171-10 | 70752017110 | 100 TABLET in 1 BOTTLE (70752-171-10)Marketed from Mar 18, 2021 | |
| 70752-171-11 | 70752017111 | 1000 TABLET in 1 BOTTLE (70752-171-11)Marketed from Mar 18, 2021 |
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
- QUAGEN PHARMACEUTICALS LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080154
- Marketing start
- Listing expires
- Other FDA classes
- Thyroid Hormone Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 70752-171_4a15d422-7a6a-4b92-a4cf-3632250c9580SPL ID 4a15d422-7a6a-4b92-a4cf-3632250c9580SPL set ID 84eae11a-b572-4570-b288-ac2cdd374186RxCUI 198175UNII 721M9407IYUPC 0370752171113
- 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
N470752017110followed by a unit qualifier and the quantityPackage 70752-0171-10. 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.
Other NDCs under ANDA 080154
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 | Bryant Ranch Prepack | 71335-2901 |
| Propylthiouracil | Propylthiouracil 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2072 |