Prescription drug · UNAPPROVED DRUG OTHER
PureLife APF (Sodium fluoride) NDC 68987-013
Sodium fluoride 5.6 g/454g · Gel · Dental · PureLife Dental
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68987-013-15 | 68987001315 | 454 g in 1 BOTTLE, PLASTIC (68987-013-15)Marketed from Jul 1, 2016 |
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)
- PureLife APF
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 5.6 g/454g
- Dosage form
- Gel
- Route
- Dental
- Labeler
- PureLife DentalNDC labeler code 68987
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 68987-013_d5f3e776-11f8-7413-e053-2995a90a4603SPL ID d5f3e776-11f8-7413-e053-2995a90a4603SPL set ID c8262117-43e6-4771-93ac-618e0f2c8c41RxCUI 245593UNII 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
N468987001315followed by a unit qualifier and the quantityPackage 68987-0013-15. 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 A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Excerpt only. Read the full label for complete information.
About NDC 68987-013
- What is NDC 68987-013?
- 68987-013 is the product NDC for PureLife APF (sodium fluoride), Sodium fluoride 5.6 g/454g gel, listed with the FDA by PureLife Dental. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PureLife APF (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- PureLife Dental, NDC labeler code 68987. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PureLife APF?
- 4 other product NDCs are listed under this name. See all PureLife APF NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other PureLife APF products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PureLife APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | PureLife Dental | 68987-010 | 68987-0010-15 |
| PureLife APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | PureLife Dental | 68987-011 | 68987-0011-15 |
| PureLife APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | PureLife Dental | 68987-012 | 68987-0012-15 |
| PureLife APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | PureLife Dental | 68987-014 | 68987-0014-15 |