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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 — NDC 0642-0076-03 (Billing 00642-0076-03)

by Exeltis USA, Inc · 1 KIT in 1 CARTON * 30 TABLET, COATED in 1 BOX * 30 CAPSULE in 1 BOX

This is a 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 from Exeltis USA, Inc, marketed since Feb 2007 and currently FDA-listed.

NDC 00642-0076-03
🏷️ FDA NDC (as labeled) 0642-0076-03 billing pads the labeler segment with a zero
This package
Contains1 kit in 1 carton * 30 tablet, coated in 1 box * 30 capsule in 1 box Pack sizes2 compare ↓
Product page 00642-0076-30 Also comes in: 30 tablets 0642-0076-30
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0642-0076-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0642 labeler · 0076 product · 03 package
Package marketed since
Feb 16, 2007
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0642007603 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0642-0076-03
Product NDC 0642-0076
11-digit billing NDC 00642007603
RxCUI 1100198
SPL Set ID a0e273e2-0876-4830-a903-282085be7f32
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-02-16
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 78516020006330
GPI class Vitafol-OB+DHA
GCN Seq No 062235
GCN 98019
HICL code 034458
Ingredient (HICL) Prenatal Vit 10/Iron/Folic/Dha
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6F
Therapeutic class — specific (HIC3) Prenatal Vitamin Preparations
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name VITAFOL-OB+DHA COMBO PACK
FDB brand name Vitafol-Ob+Dha
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 062235
  • GCN: 98019
  • GPI-14 (Medi-Span): 78516020006330
  • HICL (First Databank): 034458
  • AHFS class code: 20:04.04.00
  • RxCUI (RxNorm): 1100198
Why two NDCs? The FDA registers this code as 0642-0076-03 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00642-0076-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name VITAFOL-OB+DHA COMBO PACK Ingredient Prenatal Vit 10/Iron/Folic/Dha
🧪 What is this product?

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.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00642-0076-03 You're viewing this 1 KIT in 1 CARTON * 30 TABLET, COATED in 1 BOX * 30 CAPSULE in 1 BOX Sample — — 2007-02-16 — Active
00642-0076-30 0642-0076-30 Main listing 1 KIT in 1 CARTON * 30 TABLET, COATED in 1 BOX * 30 CAPSULE in 1 BOX $2.39 / ea — 2007-02-16 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 carton * 30 tablet, coated in 1 box * 30 capsule in 1 box.
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?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vitafol-OB Plus DHA Prenatal Supplement Plus DHAthis 00642-0076-03 Exeltis 30 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Feb 2007
📍
2026
Currently FDA-listed
19 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue / yellow
ShapeOval
ImprintEV0079
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerExeltis USA, Inc
Labeler code00642
First marketedFeb 2007
Product typeHuman Prescription Drug

More NDCs from Exeltis USA, Inc labeler code 00642

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 39 words ▾

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 47 words ▾

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 24 words ▾

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 101 words ▾

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 170 words ▾

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 64 words ▾

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 75 words ▾

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 6 words ▾

Pediatric Use Not for pediatric use.

📦 How Supplied / Storage and Handling 59 words ▾

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 12 words ▾

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

📋 Description 119 words ▾

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 23 words ▾

Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

📄 Package Label / Principal Display Panel 45 words ▾

PRINCIPAL DISPLAY PANEL - Kit Carton 0642-0076-30 Vitafol ® -OB+DHA Prenatal Supplement with DHA SUGAR, LACTOSE, GLUTEN AND IODINE FREE New Smaller DHA Softgel DOES NOT CONTAIN FISH OIL R X Unit Dose Pack 30 Caplets and 30 Softgel Capsules U.S. Patented Vitafol OB+DHA Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets00642-0076-30 7,975 Rx · $1,189,503
30 tablets this page00642-0076-03 No Medicaid data
Drug total (last 4 qtrs): 7,975 Rx · 283,648 units · $1,189,503 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

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 — Not published for this NDC No photo available yet for this listing.
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exeltis USA, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (00642-0076-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Exeltis USA, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00642-0075-30 · Exeltis 00642-0093-03 · Exeltis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.