NDC 42192-0321-30 — PNV-DHA ascorbic acid, cholecalciferol

🆔 Identity & classification

FDA NDC (as labeled) 42192-321-30

Product NDC 42192-321

11-digit billing NDC 42192032130

NCPDP billing unit EA — each (per item)

UNII PQ6CK8PD0R, 1C6V77QF41, WR1WPI7EW8, KV2JZ1BI6Z, 935E97BOY8, P6YC3EG204 +4 more

UPC 0342192321304

SPL Set ID 038fe2e7-dc16-485c-b5fb-746db7231347

Established class (EPC) Vitamin C; Vitamin D; Vitamin B6 Analog; Vitamin B12; Calcium

Chemical class Ascorbic Acid; Vitamin D; Vitamin B 6; Analogs/Derivatives; Vitamin B 12; Calcium

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2009-11-02

Route ORAL

Dosage form CAPSULE, GELATIN COATED

Substance ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; MAGNESIUM; DOCONEXENT

GCN Seq No 065192

GCN 23495

HICL code 036324

Ingredient (HICL) Multivit 47/Iron/Folate 1/Dha

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C6

Therapeutic class — intermediate (HIC2) Vitamins

HIC3 code C6Z

Therapeutic class — specific (HIC3) Multivitamin Preparations

AHFS code 20:04.04.00

AHFS class Iron Preparations

FDB label name PNV-DHA SOFTGEL

FDB brand name Pnv-Dha

Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation

Why two NDCs? The FDA registers this code as 42192-321-30 — a 5-3-2 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 product segment → 42192-0321-30. 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.

🏭 Manufacturer & labeler

LabelerAcella Pharmaceuticals, LLC

Labeler code42192

First marketedNov 2009

Product typeHuman Prescription Drug

Portfolio36 products on file

🔎 All NDCs from Acella Pharmaceuticals, LLC

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.

🩺 Clinical

Label name PNV-DHA SOFTGEL Ingredient Multivit 47/Iron/Folate 1/Dha

🧪 What is this product?

This is an oral gelatin capsule containing a combination of vitamins and minerals. Ascorbic acid, cholecalciferol, pyridoxine, folic acid, and cyanocobalamin are B and C vitamins typically used to supplement dietary intake, while ferrous fumarate is an iron compound commonly included in nutritional formulations. Calcium and magnesium are minerals often used to support bone and muscle function. Alpha-tocopherol acetate (vitamin E) and docosahexaenoic acid (DHA) are typically included for their nutritional roles. This product is marketed without an approved FDA application.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color blue

ShapeCapsule

ImprintBP;321

Size25 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
UNII F5AJW0ONK4
A protein derived from animal bone and connective tissue. It forms the capsule shell that holds the medicine inside and helps the capsule dissolve in the stomach so the drug can be absorbed.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
UNII 5QUO05548Z
Palm oil is a natural plant-based fat extracted from palm fruit. It's used as a lubricant, binder, or coating agent to help the medicine hold together, flow smoothly during manufacturing, and sometimes improve how the body absorbs the active ingredient.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPNV-DHA contains fish oil and soy. OTHER INGREDIENTS: Beeswax, soy lecithin and vegetable shortening. Coating contains: Bovine gelatin, FD&C Blue No. 1, FD&C Red No. 3, glycerin, purified water and titanium dioxide. Contains Soy.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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	$0.986	$29.57 / 30 capsules
Medicaid paysCMS SDUD · 12 mo	$1.06	$31.71 / 30 capsules
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 2% over the last 24 months.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Pnv-Dha 85 [iU]/1; 200 [iU]/1; 10 [iU]/1; 25 [iU]/1; 1 mg/1; 12 ug/1; 140 mg/1; 27 mg/1; 45 mg/1; 300 mgthis 42192-0321-30	Acella	30 capsules	$0.986	—	Availability likely	—

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

🏛️

2009

On the market since

Nov 2009

📍

2026

Currently FDA-listed

17 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42192-0321-30, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q1 2026 · 5 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

4.2K

Units reimbursed last 4 qtrs

200.6K

Gross reimbursed last 4 qtrs

$212K

Avg / prescription

$50.50

Avg / unit

$1.0571

Latest quarter Q1 2026

951Rx

Medicaid pays / ea

$1.0571

gross reimbursed

vs

NADAC / ea

$0.9857

acquisition cost

=

Spread

+$0.0714

+7% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

90% MCO

Fee-for-service · 422 Rx Managed care · 3,777 Rx

State Medicaid map

Units reimbursed · per 100k residents

2.3757

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Ohio 757 /100k

2 Hawaii 610 /100k

3 Connecticut 603 /100k

4 North Carolina 253 /100k

5 Louisiana 199 /100k

6 Massachusetts 153 /100k

7 Maryland 94.1 /100k

8 Indiana 89.2 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for PNV-DHA — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name PNV-DHA. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$3.9K

Claims incl. refills

48

Beneficiaries

40

Spend / beneficiary

$97.70

Spend / claim

$81.41

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PNV-DHA (this brand).

Top reported reactions

Premature Delivery2

Discomfort1

Foetal Exposure During Pregnancy1

Induced Labour1

Premature Baby1

Vaginal Haemorrhage1

Age at onset

Adult1

Reporter sex

Female · 100%

Serious outcomes

Hospitalization3

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
42192-0321-30 You're viewing this	30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-321-30)	2009-11-02	Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

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.

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)	✓ 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

“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.

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 FDA registers it as 42192-321-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 42192-0321-30, written without dashes as 42192032130. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 42192-0321-30, the first segment (42192) is the labeler code FDA assigned to Acella Pharmaceuticals, LLC; the middle segment (0321) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Acella Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Acella Pharmaceuticals, LLC 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.

📄 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 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 🧪 Inactive Ingredients 📋 Description

🚨 Boxed Warning 97 words ▾

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

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 poison control center immediately.

🎯 Indications and Usage 32 words ▾

INDICATIONS: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

⏱️ Dosage and Administration 17 words ▾

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS: PNV-DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients.

🤒 Adverse Reactions 16 words ▾

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

📦 How Supplied / Storage and Handling 65 words ▾

HOW SUPPLIED: Bottles of 30 softgels (42192-321-30). The listed product number is not a National Code. Instead, Acella Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

🧪 Inactive Ingredients 34 words ▾

PNV-DHA contains fish oil and soy. OTHER INGREDIENTS: Beeswax, soy lecithin and vegetable shortening. Coating contains: Bovine gelatin, FD&C Blue No. 1, FD&C Red No. 3, glycerin, purified water and titanium dioxide. Contains Soy.

📋 Description 130 words ▾

DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is cobalt blue in color, opaque and imprinted with “BP 321” on one side and blank on the other. PNV-DHA can also be beneficial in improving the nutritional status of women prior to conception.

Supplement Facts Panel PNV-DHA contains fish oil and soy. OTHER INGREDIENTS: Beeswax, soy lecithin and vegetable shortening. Coating contains: Bovine gelatin, FD&C Blue No.

1, FD&C Red No. 3, glycerin, purified water and titanium dioxide. Contains Soy.

INDICATIONS: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. CONTRAINDICATIONS: PNV-DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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

🔗 Related NDC lookups

🧪 All Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, Ferrous Fumarate, Magnesium, Doconexent NDCsSame ingredient 🏭 All Acella labeler NDCsLabeler code 42192 📚 All Calcium NDCsDrug class

PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent 85 [iU]/1; 200 [iU]/1; 10 [iU]/1; 25 [iU]/1; 1 mg; 12 ug; 140 mg; 27 mg; 45 mg; 300 mg Capsule, Gelatin Coated, 30-count

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups