Over-the-counter drug · ANDA
ThyroSafe (Potassium iodide) NDC 50633-910
Potassium iodide 65 mg/1 · Tablet · Oral · BTG International Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50633-910-20 | 5063309102050633091020 | 160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2002 |
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)
- ThyroSafe
- Generic name (nonproprietary)
- potassium iodide
- Active ingredients
- Potassium iodide — 65 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BTG International Inc.NDC labeler code 50633
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076350
- Marketing start
- Listing expires
- Identifiers
- Product ID 50633-910_59f62079-e6fd-0d8d-e063-6394a90aa5c0SPL ID 59f62079-e6fd-0d8d-e063-6394a90aa5c0SPL set ID 47762f8f-30e2-445d-aaa1-e04479f8dd5bRxCUI 430174, 1086474UNII 1C4QK22F9JUPC 0350633910208
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
N450633091020followed by a unit qualifier and the quantityPackage 50633-0910-20. 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 .
Indications (excerpt from the label)
DIRECTIONS FOR USE Use only as directed by public officials if a nuclear radiation emergency happens.
Excerpt only. Read the full label for complete information.
About NDC 50633-910
- What is NDC 50633-910?
- 50633-910 is the product NDC for ThyroSafe (potassium iodide), Potassium iodide 65 mg/1 tablet, listed with the FDA by BTG International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ThyroSafe (Potassium Iodide).
- What is the active ingredient?
- Potassium iodide.
- Who is the labeler?
- BTG International Inc., NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ThyroSafe?
- 1 other product NDC are listed under this name. See all ThyroSafe NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ThyroSafe products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Thyrosafepotassium iodide | Potassium iodide 130 mg/1 | TabletOral | BTG International Inc | 50633-920 | 50633-0920-20 |
Other NDCs under ANDA 076350
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 |
|---|---|---|---|---|
| Thyrosafepotassium iodide | Potassium iodide 130 mg/1 | TabletOral | BTG International Inc | 50633-920 |