NDC codes

FDA NDC Directory
Product NDC (as listed)75854-314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75854-0314Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
75854-314-30758540314307585403143030 TABLET, COATED in 1 BOTTLE (75854-314-30)Marketed from Jun 5, 2014

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)
Prenate Elite
Generic name (nonproprietary)
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide
Active ingredients
Vitamin a — 780 ug/1Ascorbic acid — 75 mg/1Cholecalciferol — 15 ug/1.alpha.-tocopherol acetate, Dl- — 18 mg/1Thiamine mononitrate — 3 mg/1Riboflavin — 3.5 mg/1Niacinamide — 21 mg/1Pyridoxine hydrochloride — 21 mg/1Folic acid — 400 ug/1Levomefolate calcium — 600 ug/1Calcium formate — 160 mg/1Ferrous asparto glycinate — 20 mg/1Cyanocobalamin — 13 ug/1Biotin — 330 ug/1Potassium iodide — 150 ug/1Magnesium oxide — 25 mg/1Zinc oxide — 15 mg/1Cupric oxide — 1.5 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Avion Pharmaceuticals, LLCNDC labeler code 75854
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Analogs/Derivatives (Chemical/Ingredient)Ascorbic Acid (Chemical structure)Calcium (Chemical structure)Divalent (Chemical structure)Decreased Copper Ion Absorption (Physiologic effect)Folic Acid (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)Vitamin A (Chemical structure)Vitamin B 12 (Chemical structure)Vitamin B 6 (Chemical/Ingredient)Vitamin D (Chemical structure)
Identifiers
Product ID 75854-314_5609acca-0594-805f-e063-6394a90afc60SPL ID 5609acca-0594-805f-e063-6394a90afc60
Pharmacologic class
Blood Coagulation Factor; Calculi Dissolution Agent; Copper Absorption Inhibitor; Folate Analog; Osmotic Laxative; Phosphate Binder; Vitamin A; Vitamin B12; Vitamin B6 Analog; Vitamin C; Vitamin D

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

N475854031430 followed by a unit qualifier and the quantity

Package 75854-0314-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 75854-314

What is NDC 75854-314?
75854-314 is the product NDC for Prenate Elite, Vitamin a 780 ug/1 + 17 more ingredients tablet, coated, listed with the FDA by Avion Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Prenate Elite (.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide).
What is the active ingredient?
Vitamin a, Ascorbic acid, Cholecalciferol, .alpha.-tocopherol acetate, Dl-, Thiamine mononitrate, Riboflavin, Niacinamide, Pyridoxine hydrochloride, Folic acid, Levomefolate calcium, Calcium formate, Ferrous asparto glycinate, Cyanocobalamin, Biotin, Potassium iodide, Magnesium oxide, Zinc oxide, Cupric oxide.
Who is the labeler?
Avion Pharmaceuticals, LLC, NDC labeler code 75854. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prenate Elite?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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