Prescription drug · UNAPPROVED DRUG OTHER
Vitafol Ultra NDC 0642-0093
Doconexent 200 mg/1 + 16 more ingredients · Capsule, Liquid filled · Oral · Exeltis USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0642-0093-03 | 0064200930300642009303 | 1 BLISTER PACK in 1 BOX (0642-0093-03) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Sep 23, 2013 | |
| 0642-0093-30 | 0064200933000642009330 | 5 BLISTER PACK in 1 BOX (0642-0093-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Sep 23, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Vitafol UltraSuffix: Ultra
- Generic name (nonproprietary)
- doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, .beta.-carotene, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc oxide, cupric oxide, potassium iodide, magnesium oxide, folic acid, and levomefolate calcium
- Active ingredients
- Doconexent — 200 mg/1Niacinamide — 15 mg/1.alpha.-tocopherol acetate, Dl- — 9 mg/1Cholecalciferol — 25 ug/1Beta carotene — 330 ug/1Ascorbic acid — 30 mg/1Thiamine mononitrate — 1.6 mg/1Riboflavin — 1.8 mg/1Pyridoxine hydrochloride — 2.5 mg/1Cyanocobalamin — 12 ug/1Iron — 29 mg/1Zinc oxide — 25 mg/1Cupric oxide — 2 mg/1Potassium iodide — 150 ug/1Magnesium oxide — 20 mg/1Folic acid — 680 ug/1Levomefolate calcium — 1020 ug/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Exeltis USA, Inc.NDC labeler code 0642
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Ascorbic Acid (Chemical structure)Folic Acid (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 0642-0093_303eca3e-0bc8-1bf8-e063-6294a90a82d8SPL ID 303eca3e-0bc8-1bf8-e063-6294a90a82d8SPL set ID 40fa2c3a-f41f-434c-91de-5150a18d3e4bUNII ZAD9OKH9JC, 25X51I8RD4, WR1WPI7EW8, 1C6V77QF41, 01YAE03M7J, PQ6CK8PD0R, 8K0I04919X, TLM2976OFR, 68Y4CF58BV, P6YC3EG204, E1UOL152H7, SOI2LOH54Z, V1XJQ704R4, 1C4QK22F9J, 3A3U0GI71G, 935E97BOY8, A9R10K3F2FUPC 0306420093302
- Pharmacologic class
- Calculi Dissolution Agent; Folate Analog; 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
N400642009303followed by a unit qualifier and the quantityPackage 00642-0093-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
USAGE Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.* Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.
Excerpt only. Read the full label for complete information.
About NDC 0642-0093
- What is NDC 0642-0093?
- 0642-0093 is the product NDC for Vitafol Ultra, Doconexent 200 mg/1 + 16 more ingredients capsule, liquid filled, listed with the FDA by Exeltis USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vitafol Ultra (Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium).
- What is the active ingredient?
- Doconexent, Niacinamide, .alpha.-tocopherol acetate, Dl-, Cholecalciferol, Beta carotene, Ascorbic acid, Thiamine mononitrate, Riboflavin, Pyridoxine hydrochloride, Cyanocobalamin, Iron, Zinc oxide, Cupric oxide, Potassium iodide, Magnesium oxide, Folic acid, Levomefolate calcium.
- Who is the labeler?
- Exeltis USA, Inc., NDC labeler code 0642. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vitafol Ultra?
- 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.