Prescription drug · UNAPPROVED DRUG OTHER
Alpha-Pro (Sodium fluoride and hydrofluoric acid) NDC 55346-0943
Sodium fluoride 7.9 mg/g; Hydrofluoric acid 4.4 mg/g · Gel · Dental · Dental Technologies, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55346-0943-1 | 55346094301 | 497 g in 1 BOTTLE (55346-0943-1)Marketed from Apr 1, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Alpha-Pro
- Generic name (nonproprietary)
- sodium fluoride and hydrofluoric acid
- Active ingredients
- Sodium fluoride — 7.9 mg/gHydrofluoric acid — 4.4 mg/g
- Dosage form
- Gel
- Route
- Dental
- Labeler
- Dental Technologies, Inc.NDC labeler code 55346
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 55346-0943_42c899b3-99ed-0863-e063-6394a90ad112SPL ID 42c899b3-99ed-0863-e063-6394a90ad112SPL set ID a86ec65f-f6e1-474d-aeff-412a4716a92cRxCUI 1297381UNII 8ZYQ1474W7, RGL5YE86CZ
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
N455346094301followed by a unit qualifier and the quantityPackage 55346-0943-01. 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: Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times per year.
Excerpt only. Read the full label for complete information.
About NDC 55346-0943
- What is NDC 55346-0943?
- 55346-0943 is the product NDC for Alpha-Pro, Sodium fluoride 7.9 mg/g; Hydrofluoric acid 4.4 mg/g gel, listed with the FDA by Dental Technologies, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alpha-Pro (Sodium Fluoride and Hydrofluoric Acid).
- What is the active ingredient?
- Sodium fluoride, Hydrofluoric acid.
- Who is the labeler?
- Dental Technologies, Inc., NDC labeler code 55346. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alpha-Pro?
- 1 other product NDC are listed under this name. See all Alpha-Pro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alpha-Pro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alpha-Prosodium fluoride and hydrofluoric acid | Sodium fluoride 7.9 mg/g; Hydrofluoric acid 4.4 mg/g | GelDental | Dental Technologies, Inc. | 55346-0942 | 55346-0942-01 |