NDC 15370-0250-30 — TriStart DHA ASCORBIC ACID, CHOLECALCIFEROL

🆔 Identity & classification

FDA NDC (as labeled) 15370-250-30

Product NDC 15370-250

11-digit billing NDC 15370025030

NCPDP billing unit EA — each (per item)

UNII PQ6CK8PD0R, 1C6V77QF41, A7E6112E4N, M572600E5P, TLM2976OFR, 2679MF687A +9 more

UPC 0315370250307

SPL Set ID 92ccf7d4-4527-49f0-b890-1a11b5a10086

Established class (EPC) Vitamin C; Vitamin D; Nicotinic Acid; Vitamin B12

Chemical class Ascorbic Acid; Vitamin D; Nicotinic Acids; Vitamin B 12

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-06-01

Route ORAL

Dosage form CAPSULE, LIQUID FILLED

Substance ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; IC

GPI-14 78516023000140

GPI class TriStart DHA

GCN Seq No 074232

GCN 38736

HICL code 042128

Ingredient (HICL) Prenatal 93/Iron/Folate 9/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 TRISTART DHA SOFTGEL

FDB brand name Tristart Dha

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

Why two NDCs? The FDA registers this code as 15370-250-30 — 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 → 15370-0250-30. 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

LabelerCarWin Pharmaceutical Associates, LLC

Labeler code15370

First marketedJun 2015

Product typeHuman Prescription Drug

Portfolio17 products on file

🔎 All NDCs from CarWin Pharmaceutical Associates, 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 TRISTART DHA SOFTGEL Ingredient Prenatal 93/Iron/Folate 9/Dha

🧪 What is this product?

TriStart DHA is an oral liquid-filled capsule containing multiple vitamins and minerals. The product includes B vitamins (thiamine, riboflavin, niacin, pyridoxine, cyanocobalamin, and folic acid forms), vitamin C, vitamin D, vitamin E, iron, magnesium, potassium iodide, and docosahexaenoic acid (DHA). These ingredients are components commonly found in multivitamin and nutritional supplement products. This is an unapproved drug product marketed without FDA approval.

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 Brown

ShapeOval

ImprintTriStart

Size1 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 T9D99G2B1R
Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
UNII YC9ST449YJ
Ethyl vanillin is a synthetic vanilla flavoring compound. It's added to medicines to mask bitter or unpleasant tastes, making them easier to take.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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 5EVU04N5QU
A natural or synthetic colorant that gives the medicine an orange hue. It helps identify the medication and may improve appearance.
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.
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.

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

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	$8.779	$263.37 / 30 capsules
Medicaid paysCMS SDUD · 12 mo	$8.10	$243.07 / 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

▲ Up 29% over the last 4 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
TriStart DHA 55 mg/1; 1000 [iU]/1; 15 [iU]/1; 1.3 mg/1; 1.8 mg/1; 5 mg/1; 35 mg/1; 600 ug/1; 400 ugthis 15370-0250-30	CarWin	30 capsules	$8.779	—	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

🏛️

2015

On the market since

Jun 2015

📍

2026

Currently FDA-listed

11 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 15370-0250-30, 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 – Q4 2025 · 4 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

392

Units reimbursed last 4 qtrs

20.3K

Gross reimbursed last 4 qtrs

$164.8K

Avg / prescription

$420.41

Avg / unit

$8.1023

Latest quarter Q4 2025

218Rx

Medicaid pays / ea

$8.1023

gross reimbursed

vs

NADAC / ea

$8.7791

acquisition cost

=

Spread

−$0.6768

-8% 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 ⓘ

89% FFS

Fee-for-service · 347 Rx Managed care · 45 Rx

State Medicaid map

Units reimbursed · per 100k residents

12.193.2

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 New York 93.2 /100k

2 Louisiana 29.5 /100k

3 Missouri 12.1 /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.

🔬 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 TriStart DHA (this brand).

Top reported reactions

Vomiting3

Abdominal Pain Upper2

Fatigue2

Hepatocellular Carcinoma2

Seasonal Allergy2

Abnormal Uterine Bleeding1

Ankylosing Spondylitis1

Reporter sex

Female · 100%

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
15370-0250-30 You're viewing this	30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (15370-250-30)	2015-06-01	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	— Not published for this NDC No photo available yet for this listing.
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 15370-250-30, 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: 15370-0250-30, written without dashes as 15370025030. 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 15370-0250-30, the first segment (15370) is the labeler code FDA assigned to CarWin Pharmaceutical Associates, LLC; the middle segment (0250) 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 CarWin Pharmaceutical Associates, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

CarWin Pharmaceutical Associates, 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 ⚠️ Warnings 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description

🚨 Boxed Warning 38 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 poison control center immediately.

🎯 Indications and Usage 73 words ▾

INDICATIONS TriStart DHA™ is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA™ can also be beneficial in improving the nutritional status of women prior to conception. This statement has not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure, or prevent disease.

⏱️ Dosage and Administration 29 words ▾

DIRECTIONS Adults Take one softgel daily with or without food, or as prescribed by a healthcare practitioner. Children under 12 Consult a doctor. Do not exceed the recommended dose.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

⚠️ Warnings 28 words ▾

Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.

🤒 Adverse Reactions 45 words ▾

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED TriStart DHA™ is available as oval, brown softgel capsules with a yellow imprint "TriStart". They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in a 3ct professional sample (15370-250-03). Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] TriStart DHA™ should be administered only under the direct supervision of a healthcare practitioner.

Avoid excessive heat, light and moisture. Keep out of reach of children. Tamper Evident Do not use if seal is broken or missing.

📦 Storage and Handling 40 words ▾

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] TriStart DHA™ should be administered only under the direct supervision of a healthcare practitioner. Avoid excessive heat, light and moisture. Keep out of reach of children.

📋 Description 200 words ▾

Supplement Facts Serving Size: 1 Softgel Servings per container: 30 Amount Per Serving %Daily Value %Daily Value for Pregnant and Lactating Women Vitamin C 55 mg 92% 92% (as ascorbic acid) Vitamin D3 1000 IU 250% 250% (as cholecalciferol) Vitamin E 15 IU 50% 50% (as d-alpha-tocopheryl acetate) Thiamin 1.3 mg 87% 76% (as thiamine HCl, Vitamin B1) Riboflavin (Vitamin B2) 1.8 mg 106% 90% Niacin (as nicotinic acid) 5 mg 25% 25% Vitamin B6 35 mg 1750% 1400% (as pyridoxine HCl) Folate (as 630 mcg of L-Methylfolate Magnesium, molar equivalent to 600mcg of L-Methylfolic acid; and 400mcg of folic acid) 1 mg 250% 125% Vitamin B12 14 mcg 233% 175% (as cyanocobalamin) Iron (as carbonyl iron) 31 mg 172% 172% Iodine 200 mcg 133% 133% (as Potassium Iodide) Magnesium 30 mg 8% 7% (as Magnesium Oxide) Docosahexaenoic Acid 200mg Daily Values (DV) not established.

(DHA) Eicosapentaenoate Acid 15 mg (EPA) OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin. Contains: Soy and Fish TriStart DHA™ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners.

TriStart DHA™ contains bovine gelatin.

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, D-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Levomefolate Magnesium, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Potassium Iodide, Magnesium Oxide, Doconexent, An NDCsSame ingredient 🏭 All CarWin labeler NDCsLabeler code 15370 📚 All Calculi Dissolution Agent NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Prenatal Vitamin Preparations.

Prenatal Vit 10/Iron/Folic/Dha 00642-0076-03 Prenatal Vit 10/Iron Fum/Folic 00642-0079-12 Pnv 11/Iron Fum/Folic Acid/Om3 23359-0105-30 Pnv,Calcium 72/Iron/Folic Acid 39328-0106-10 Prenatal,Calc 40/Iron/Folate 1 42192-0320-90 Pnv 66/Iron/Folic/Docusate/Dha 42192-0323-30 Pnv 69/Iron/Folic/Docusate/Dha 42192-0343-30

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.