Prescription drug · UNAPPROVED DRUG OTHER
Tri-Vite Drops with Fluoride NDC 58657-323
ascorbic acid, sodium fluoride, vitamin a and vitamin d · Vitamin a 1500 [iU]/mL + 3 more ingredients · Solution · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-323-50 | 5865703235058657032350 | 1 BOTTLE, DROPPER in 1 CARTON (58657-323-50) / 50 mL in 1 BOTTLE, DROPPERMarketed from Jul 25, 2018 |
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)
- Tri-Vite Drops with Fluoride
- Generic name (nonproprietary)
- ascorbic acid, sodium fluoride, vitamin a and vitamin d
- Active ingredients
- Vitamin a — 1500 [iU]/mLAscorbic acid — 35 mg/mLVitamin d — 400 [iU]/mLSodium fluoride — .25 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLCNDC labeler code 58657
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Ascorbic Acid (Chemical structure)Vitamin A (Chemical structure)
- Identifiers
- Product ID 58657-323_41b76910-3e17-3254-e063-6294a90adb54SPL ID 41b76910-3e17-3254-e063-6294a90adb54SPL set ID 003181d4-5412-4ffe-b99d-880f2010e3adRxCUI 1365980UNII 81G40H8B0T, PQ6CK8PD0R, 9VU1KI44GP, 8ZYQ1474W7
- Pharmacologic class
- Vitamin A; Vitamin C
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
N458657032350followed by a unit qualifier and the quantityPackage 58657-0323-50. 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 Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provide…
Excerpt only. Read the full label for complete information.
About NDC 58657-323
- What is NDC 58657-323?
- 58657-323 is the product NDC for Tri-Vite Drops with Fluoride, Vitamin a 1500 [iU]/mL + 3 more ingredients solution, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tri-Vite Drops with Fluoride (ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D).
- What is the active ingredient?
- Vitamin a, Ascorbic acid, Vitamin d, Sodium fluoride.
- Who is the labeler?
- Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tri-Vite Drops with Fluoride?
- 3 other product NDCs are listed under this name. See all Tri-Vite Drops with Fluoride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tri-Vite Drops with Fluoride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tri-Vite Drops with Fluorideascorbic acid, sodium fluoride, vitamin a and vitamin d | Vitamin a 1500 [iU]/mL + 3 more ingredients | SolutionOral | Method Pharmaceuticals, LLC | 58657-324 | 58657-0324-50 |
| Tri-Vite Drops with Fluorideascorbic acid, sodium fluoride, vitamin a and vitamin d | Vitamin a 1500 [iU]/mL + 3 more ingredients | SolutionOral | Bryant Ranch Prepack | 63629-1141 | 63629-1141-01 |
| Tri-Vite Drops with Fluorideascorbic acid, sodium fluoride, vitamin a and vitamin d | Vitamin a 1500 [iU]/mL + 3 more ingredients | SolutionOral | Bryant Ranch Prepack | 72162-1659 | 72162-1659-02 |