Prescription drug · ANDA
Propylthiouracil NDC 62135-606
Propylthiouracil 50 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-606-90 | 62135060690 | 90 TABLET in 1 BOTTLE (62135-606-90)Marketed from Dec 19, 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
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080016
- Marketing start
- Listing expires
- Other FDA classes
- Thyroid Hormone Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-606_0d6cc91d-1da2-25ae-e063-6394a90aa6a0SPL ID 0d6cc91d-1da2-25ae-e063-6394a90aa6a0SPL set ID 53c5f586-3e72-479d-89ba-379683c8f6baRxCUI 198175UNII 721M9407IYUPC 0362135606909
- 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
N462135060690followed by a unit qualifier and the quantityPackage 62135-0606-90. 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 62135-606
- What is NDC 62135-606?
- 62135-606 is the product NDC for Propylthiouracil, Propylthiouracil 50 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 | Par Health USA, LLC | 67253-651 | 67253-0651-1067253-0651-11 |