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TriStart DHA 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 55 mg; 1000 [iU]/1; 15 [iU]/1; 1.3 mg; 1.8 mg; 5 mg; 35 mg; 600 ug; 400 ug Capsule, Liquid Filled, 30-count — NDC 15370-250-30 (Billing 15370-0250-30)

by CarWin Pharmaceutical Associates, LLC · 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

This is a package of 30 capsules of TriStart DHA 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 55 mg; 1000 [iU]/1; 15 [iU]/1; 1.3 mg; 1.8 mg; 5 mg; 35 mg; 600 ug; 400 ug Capsule, Liquid Filled from CarWin Pharmaceutical Associates, LLC, marketed since Jun 2015 and currently FDA-listed; retail pharmacies pay about $8.78 per capsule (NADAC). It is this product's only package size.

NDC 15370-0250-30
🏷️ FDA NDC (as labeled) 15370-250-30 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 15370-250-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
15370 labeler · 250 product · 30 package
Package marketed since
Jun 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC)
0315370250307
Medicaid fills, this package
1,436 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

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

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
Quick answers
  • GSN (GCN sequence number): 074232
  • GCN: 38736
  • GPI-14 (Medi-Span): 78516023000140
  • HICL (First Databank): 042128
  • AHFS class code: 20:04.04.00
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.

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.

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 eaPer package
Retail pharmacies payNADAC · weekly $8.779 $263.37 / 30 capsules
Medicaid paysCMS SDUD · 12 mo $8.06 $241.84 / 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
Sep 2021 Mar 2022 Sep 2022 Mar 2023 $8.779 $6.790
▲ 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
15370-0250-30 You're viewing this Main listing 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2015-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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.

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.

Manufacturer & labeler

LabelerCarWin Pharmaceutical Associates, LLC
Labeler code15370
First marketedJun 2015
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from CarWin Pharmaceutical Associates, LLC labeler code 15370

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 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🚨 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.

⚠️ Precautions 104 words ▾

PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA and EPA) 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.

📄 Package Label / Principal Display Panel 31 words ▾

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label 15370-250-30 TriStart DHA PRENATAL SUPPLEMENT Dye Free, Lactose, Gluten and Sugar Free Rx 30 Softgels Principal Display Panel - 30 Capsule Bottle Label

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

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 this package alone, 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
1.4K
Units reimbursed last 4 qtrs
81.8K
Gross reimbursed last 4 qtrs
$659.5K
Avg / prescription
$459.26
Avg / unit
$8.0613
Latest quarter Q1 2026
1.1KRx
Medicaid pays / ea
$8.0613
gross reimbursed
vs
NADAC / ea
$8.7791
acquisition cost
=
Spread
−$0.7178
-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 ⓘ
99% FFS
Fee-for-service · 1,415 Rx Managed care · 21 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 80,070 units · 409 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 1,110 units · 30.7 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 630 units · 13.8 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
13.8409
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 409 /100k
2 Connecticut 30.7 /100k
3 Louisiana 13.8 /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

6 reports
Female · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 0
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.

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 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 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.
← 15370-0220-28 · Carwin 15370-0305-04 · Carwin →
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.