Prescription drug · UNAPPROVED DRUG OTHER
Ionite R (Sodium fluoride) NDC 53045-265
Sodium fluoride 38 g/L · Liquid · Dental, Oral · Dharma Research, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53045-265-64 | 5304502656453045026564 | 1.9 L in 1 BOTTLE, PUMP (53045-265-64)Marketed from Nov 3, 2013 |
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)
- Ionite R
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 38 g/L
- Dosage form
- Liquid
- Route
- Dental, Oral
- Labeler
- Dharma Research, Inc.NDC labeler code 53045
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53045-265_ff676d2f-3188-4d27-b6a4-83e164154381SPL ID ff676d2f-3188-4d27-b6a4-83e164154381SPL set ID 0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5RxCUI 251960UNII 8ZYQ1474W7
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N453045026564followed by a unit qualifier and the quantityPackage 53045-0265-64. 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)
INDICATIONS AND USAGE This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Excerpt only. Read the full label for complete information.
About NDC 53045-265
- What is NDC 53045-265?
- 53045-265 is the product NDC for Ionite R (sodium fluoride), Sodium fluoride 38 g/L liquid, listed with the FDA by Dharma Research, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ionite R (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Dharma Research, Inc., NDC labeler code 53045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ionite R?
- 1 other product NDC are listed under this name. See all Ionite R NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ionite R products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ionite Rsodium fluoride | Sodium fluoride 38 g/L | LiquidDental, Oral | Dharma Research, Inc. | 53045-266 | 53045-0266-64 |