Vitafol-OB Plus DHA Prenatal Supplement Plus DHA Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, Copper, and Doconexent Kit
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Vitafol-OB Plus DHA is an unapproved prescription prenatal supplement kit containing vitamins, minerals, and docosahexaenoic acid (DHA). The vitamin components, including folic acid, B vitamins, vitamin D, and vitamin A, are typically included in prenatal formulations to support maternal nutrition during pregnancy. Iron, calcium, magnesium, and zinc are minerals commonly used in prenatal products to address increased nutritional needs. DHA, an omega-3 fatty acid, is included in many prenatal supplements for its role in fetal development.
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Supplement & herbal interactions
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💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.391 | — |
| Medicaid paysCMS SDUD · 12 mo | $4.17 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vitafol-OB Plus DHA Prenatal Supplement Plus DHAthis 00642-0076-30 | Exeltis | 30 tablets | $2.391 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00642-0076-03 | 1 KIT in 1 CARTON (0642-0076-03) * 30 TABLET, COATED in 1 BOX * 30 CAPSULE in 1 BOX | — | — | 2007-02-16 | Active |
| 00642-0076-30 You're viewing this | 1 KIT in 1 CARTON (0642-0076-30) * 30 TABLET, COATED in 1 BOX * 30 CAPSULE in 1 BOX | $2.39 / ea | — | 2007-02-16 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00642-0076-30?
What NDC number is used to bill for this package of Vitafol-OB Plus DHA Prenatal Supplement Plus DHA Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, Copper, and Doconexent Kit?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Is this NDC FDA-approved?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Warning Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Vitafol ® -OB+DHA 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.* Vitafol ® -OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Before, during and after pregnancy, take one caplet and one soft-gel capsule by mouth daily, or as directed by a physician.
⛔ Contraindications ▾
CONTRAINDICATIONS Vitafol ® -OB+DHA is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.
Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12).
⚠️ Warnings ▾
WARNINGS/PRECAUTIONS Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathryroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.
Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.
Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids, such as DHA exceeding 2 grams per day is not recommended. Avoid overdosage.
Keep out of the reach of children.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® -OB+DHA. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions. Contact your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.
🔄 Drug Interactions ▾
Drug Interactions High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions.
🧒 Pediatric Use ▾
Pediatric Use Not for pediatric use.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Vitafol ® -OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 caplets and 6 softgel capsules each) (0642-0076-30) and as professional samples (0642-0076-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
📦 Storage and Handling ▾
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
📋 Description ▾
COMPOSITION Each Vitafol ® -OB caplet contains: Vitamin A (as beta carotene) 810 mcg RAE Vitamin C (as ascorbic acid) 70 mg Vitamin D (as cholecalciferol) 10 mcg Vitamin E (as dl-alpha tocopheryl acetate) 13.5 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 18 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Calcium (as calcium carbonate) 100 mg Iron (as ferrous fumarate) 65 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Each DHA softgel capsule contains: Docosahexaenoic acid (DHA) (from natural algal oil) 250 mg
💬 Information for Patients ▾
Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.