Prescription drug · UNAPPROVED DRUG OTHER
Vitafol One (prenatal supplement with dha) NDC 0642-0070
Vitamin a 330 ug/1 + 15 more ingredients · Capsule, Gelatin coated · Oral · Exeltis USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0642-0070-03 | 00642007003 | 1 BLISTER PACK in 1 BOX (0642-0070-03) / 3 CAPSULE, GELATIN COATED in 1 BLISTER PACKMarketed from Oct 1, 2018 · Sample package | |
| 0642-0070-30 | 00642007030 | 5 BLISTER PACK in 1 BOX (0642-0070-30) / 6 CAPSULE, GELATIN COATED in 1 BLISTER PACKMarketed from Jun 13, 2011 |
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 OneSuffix: One
- Generic name (nonproprietary)
- prenatal supplement with dha
- Active ingredients
- Vitamin a — 330 ug/1Ascorbic acid — 30 mg/1Thiamine mononitrate — 1.6 mg/1Riboflavin — 1.8 mg/1Niacin — 15 mg/1Pyridoxine hydrochloride — 2.5 mg/1Cyanocobalamin — .012 mg/1Folic acid — 1700 ug/1Iodine — .15 mg/1Magnesium — 20 mg/1Zinc — 25 mg/1Copper — 2 mg/1Vitamin d — 25 ug/1Omega-3 fatty acids — 200 mg/1.alpha.-tocopherol — 9 mg/1Iron — 29 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Exeltis USA, Inc.
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Ascorbic Acid (Chemical structure)Copper (Chemical structure)Decreased Embryonic Implantation (Physiologic effect)Decreased Sperm Motility (Physiologic effect)Omega-3 (Chemical structure)Inhibit Ovum Fertilization (Physiologic effect)Nicotinic Acids (Chemical structure)Vitamin A (Chemical structure)Vitamin B 12 (Chemical structure)Vitamin B 6 (Chemical/Ingredient)Vitamin D (Chemical structure)
- Identifiers
- Product ID 0642-0070_30c98709-e351-f96b-e063-6394a90a9eb5SPL ID 30c98709-e351-f96b-e063-6394a90a9eb5SPL set ID 42a5cafd-a2c0-4ac2-99c9-708642f00716RxCUI 1119569, 1119573UNII 81G40H8B0T, PQ6CK8PD0R, 8K0I04919X, TLM2976OFR, 2679MF687A, 68Y4CF58BV, P6YC3EG204, 935E97BOY8, 9679TC07X4, I38ZP9992A, J41CSQ7QDS, 789U1901C5, 9VU1KI44GP, 71M78END5S, H4N855PNZ1, E1UOL152H7UPC 0306420070303
- Pharmacologic class
- Copper-containing Intrauterine Device; Nicotinic Acid; Omega-3 Fatty Acid; 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
N400642007003followed by a unit qualifier and the quantityPackage 00642-0070-03. 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 ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*
Excerpt only. Read the full label for complete information.