NDC codes

FDA NDC Directory
Product NDC (as listed)75854-308Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75854-0308Add 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
75854-308-30758540308307585403083030 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-308-30)Marketed from Sep 17, 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)
PRENATE Restore
Generic name (nonproprietary)
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium, iron, magnesium oxide, lactic acid and doconexent
Active ingredients
Ascorbic acid — 85 mg/1Cholecalciferol — 1000 [iU]/1.alpha.-tocopherol acetate, Dl- — 10 [iU]/1Folic acid — 1 mg/1Pyridoxine hydrochloride — 25 mg/1Cyanocobalamin — 12 ug/1Biotin — 500 ug/1Calcium — 160 mg/1Iron — 27 mg/1Magnesium oxide — 45 mg/1Lactic acid — 10 mg/1Doconexent — 400 mg/1
Dosage form
Capsule, Gelatin 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
Acidifying Activity (Mechanism)Analogs/Derivatives (Chemical/Ingredient)Ascorbic Acid (Chemical structure)Calcium (Chemical structure)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)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)Vitamin B 12 (Chemical structure)Vitamin B 6 (Chemical/Ingredient)Vitamin D (Chemical structure)
Identifiers
Product ID 75854-308_58c8617b-5f76-524f-e063-6294a90af1b7SPL ID 58c8617b-5f76-524f-e063-6294a90af1b7
Pharmacologic class
Calcium; Calculi Dissolution Agent; Osmotic Laxative; 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

N475854030830 followed by a unit qualifier and the quantity

Package 75854-0308-30. 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 75854-308

What is NDC 75854-308?
75854-308 is the product NDC for PRENATE Restore, Ascorbic acid 85 mg/1 + 11 more ingredients capsule, gelatin 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 Restore (Ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium, iron, magnesium oxide, lactic acid and doconexent).
What is the active ingredient?
Ascorbic acid, Cholecalciferol, .alpha.-tocopherol acetate, Dl-, Folic acid, Pyridoxine hydrochloride, Cyanocobalamin, Biotin, Calcium, Iron, Magnesium oxide, Lactic acid, Doconexent.
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 Restore?
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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