Chromagen ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, levomefolate glucosamine, cyanocobalamin, zinc, and intrinsic factor 25 mg; 50 mg; 60 mg; 750 ug; 250 ug; 10 ug; 12 mg; 100 mg Capsule, 30-count — NDC 75854-320-30 (Billing 75854-0320-30)
by Avion Pharmaceuticals, LLC · 30 CAPSULE in 1 BOTTLE
This is a package of 30 capsules of Chromagen ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, levomefolate glucosamine, cyanocobalamin, zinc, and intrinsic factor 25 mg; 50 mg; 60 mg; 750 ug; 250 ug; 10 ug; 12 mg; 100 mg Capsule from Avion Pharmaceuticals, LLC, marketed since Jan 2017 and currently FDA-listed. It is this product's only package size.
NDC 75854-0320-30
🏷️ FDA NDC (as labeled)
75854-320-30
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 75854-320-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 75854 labeler · 320 product · 30 package
- Package marketed since
- Jan 23, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 7585432030 8
- Medicaid fills, this package
- 232 prescriptions in the last four reported quarters
- FDA record last changed
- Aug 27, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
75854-320-30
Product NDC
75854-320
11-digit billing NDC
75854032030
NCPDP billing unit
EA — each (per item)
UNII
H7426RGB3L, R5L488RY0Q, PQ6CK8PD0R, Q65PL71Q1A, 935E97BOY8, P6YC3EG204 +2 more
SPL Set ID
13c5ed58-6333-498f-9ace-1049d7ae3552
Established class (EPC)
Vitamin C; Vitamin B12
Chemical class
Ascorbic Acid; Vitamin B 12
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-01-10
Route
ORAL
Dosage form
CAPSULE
Substance
FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; INTRINSIC FACTOR
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
82992000000100
GPI class
Chromagen
GCN Seq No
077042
GCN
42916
HICL code
044047
Ingredient (HICL)
Iron/C/Folate 6/B12/Zn/Stomach
HIC1 code
C
Therapeutic class — broad (HIC1)
Electrolyte Balance/Metabolism/Nutrition
HIC2 code
C3
Therapeutic class — intermediate (HIC2)
Minerals
HIC3 code
C3B
Therapeutic class — specific (HIC3)
Iron Replacement
AHFS code
20:04.04.00
AHFS class
Iron Preparations
FDB label name
CHROMAGEN SOFTGEL
FDB brand name
Chromagen
Legend status
Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
- GSN (GCN sequence number): 077042
- GCN: 42916
- GPI-14 (Medi-Span): 82992000000100
- HICL (First Databank): 044047
- AHFS class code: 20:04.04.00
Why two NDCs?
The FDA registers this code as 75854-320-30 — 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 → 75854-0320-30. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name CHROMAGEN SOFTGEL Ingredient Iron/C/Folate 6/B12/Zn/Stomach
🧪 What is this product?
Chromagen is an oral capsule containing multiple vitamins and minerals typically used to address nutritional deficiencies. It includes iron (supplied as ferrous asparto glycinate and ferrous fumarate), vitamin C, B vitamins (folic acid, levomefolate glucosamine, and cyanocobalamin), zinc, and intrinsic factor. These ingredients are commonly included in formulations intended to support blood cell formation and general nutritional health. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, levomefolate glucosamine, cyanocobalamin, zinc, and intrinsic factor?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $18.16 | $544.81 / 30 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q3 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 75854-0320-30 You're viewing this Main listing | 30 CAPSULE in 1 BOTTLE | 2017-01-23 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Chromagen 25 mg/1; 50 mg/1; 60 mg/1; 750 ug/1; 250 ug/1; 10 ug/1; 12 mg/1; 100 mgthis 75854-0320-30 | Avion | 30 capsules | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 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 5MG5Z946UO
Carob is a natural sweetener and thickener derived from carob bean pods. It's used in medicines as a flavoring agent, sweetener, and to help bind or thicken the formulation.
-
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 A7JR5F8DLH
Gelatin Type B is a protein derived from animal bones and connective tissue. In medicines, it forms capsule shells that hold and protect the active drug, and may also act as a binder to help tablets hold together.
-
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 241ATL177A
Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
-
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 statesOTHER INGREDIENTS: Beeswax, soybean oil and soy lecithin. Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), caramel coloring, carob, glycerin, FD&C Blue #1, purified water).
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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerAvion Pharmaceuticals, LLC
Labeler code75854
First marketedJan 2017
Product typeHuman Prescription Drug
Portfolio13 products on file
More NDCs from Avion Pharmaceuticals, LLC labeler code 75854
- PRENATE Enhance ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent 85 mg; 1000 [iU]/1; 10 [iU]/1; 1 mg; 25 mg; 12 ug; 500 ug; 155 mg; 28 mg Capsule, Gelatin Coated NDC 75854-309-30
- Prenate DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, levomefolate calcium, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent 600 ug; 90 mg; 10 ug; 18 mg; 400 ug; 26 mg; 25 ug; 160 mg; 18 mg Capsule, Gelatin Coated NDC 75854-312-30
- Prenate Essential ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent 40 mg; 90 mg; 5.5 ug; 4.5 mg; 26 mg; 400 ug; 600 ug; 13 ug; 280 ug; 16 Capsule, Gelatin Coated NDC 75854-313-30
- Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin 780 ug; 75 mg; 15 ug; 18 mg; 3 mg; 3.5 mg; 21 mg; 21 mg; 400 ug Tablet, Coated NDC 75854-314-30
- Prenate Mini ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowb 280 ug; 80 mg; 9 mg; 9 mg; 150 ug; 25 mg; 350 mg; 25 mg; 600 ug; 60 mg Capsule, Gelatin Coated NDC 75854-315-30
- Prenate Pixie ascorbic acid, biotin, cholecalciferol, cyanocobalamin, levomefolate calcium, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, Docosahexaenoic acid, and blueberry 30 mg; 75 ug; 12.5 ug; 13 ug; 400 ug; 10 mg; 150 ug; 5 mg; 4.5 mg Tablet, Film Coated NDC 75854-316-30
- Nicomide niacinamide, zinc glycinate, folic acid, cupric oxide, selenium and chromium 100 ug; 2 mg; 500 ug; 750 mg; 50 ug; 27 mg Tablet NDC 75854-343-60
- Niferex ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid 75 mg; 175 mg; 750 ug; 250 ug; 25 ug; 15 mg; 150 mg Tablet NDC 75854-344-30
- Balcoltra levonorgestrel and ethinyl estradiol Kit NDC 75854-602-02
- AVERI desogestrel and ethinyl estradiol Kit NDC 75854-604-01
- Dhivy Carbidopa Levodopa 25 mg; 100 mg Tablet NDC 75854-701-01
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📦 Storage and Handling
🧪 Inactive Ingredients
📋 Description
⚠️ Precautions
📄 Package Label / Principal Display Panel
🚨 Boxed Warning ▾
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN . In case of accidental overdose, call a doctor or poison control center immediately.
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.
🎯 Indications and Usage ▾
INDICATIONS: Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.
⛔ Contraindications ▾
CONTRAINDICATIONS : Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Bottles of 30 softgels (75854-320-30). The listed product number is not a National Drug Code. Instead, Avion 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 and Handling ▾
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
🧪 Inactive Ingredients ▾
OTHER INGREDIENTS: Beeswax, soybean oil and soy lecithin. Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), caramel coloring, carob, glycerin, FD&C Blue #1, purified water).
📋 Description ▾
DESCRIPTION: Chromagen™ for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side. Chromagen Supplement Facts Panel
⚠️ Precautions ▾
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
📄 Package Label / Principal Display Panel ▾
75854-320-30 SUGAR FREE LACTOSE FREE Rx Only Dietary Supplement Chromagen™ 30 softgels Chromagen BL
No label section mentions that — try another word, or open the full label on DailyMed below.
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 – Q3 2025 · 3 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
232
Units reimbursed last 4 qtrs
6.8K
Gross reimbursed last 4 qtrs
$123.9K
Avg / prescription
$534.24
Avg / unit
$18.1603
Latest quarter Q3 2025
64Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 11 Rx Managed care · 221 Rx
State Medicaid map
Units reimbursed · per 100k residents
57.957.9
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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 Chromagen (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 28%
Female · 72%
Serious outcomes
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.
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) | — 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) | ✓ 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.
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 Avion Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Avion 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.
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.