![PRENATE Restore 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; 27 mg Capsule, Gelatin Coated, 30-count — NDC 75854-0308-30 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1076ba9a-0168-492f-ba9b-99fa02186092&name=Prenate+Restore+BL+L-0169+Rev.+0325-02.jpg)
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
PRENATE Restore 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; 27 mg Capsule, Gelatin Coated, 30-count — NDC 75854-308-30 (Billing 75854-0308-30)
by Avion Pharmaceuticals, LLC · 30 CAPSULE, GELATIN COATED in 1 BOTTLE
This is a package of 30 capsules of PRENATE Restore 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; 27 mg Capsule, Gelatin Coated from Avion Pharmaceuticals, LLC, marketed since Sep 2013 and currently FDA-listed. It is this product's only package size.
NDC 75854-0308-30
🏷️ FDA NDC (as labeled)
75854-308-30
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 75854-308-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 75854 labeler · 308 product · 30 package
- Package marketed since
- Sep 17, 2013
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 30 EA per package
- Barcode (UPC)
- 0375854308306
- Medicaid fills, this package
- 11 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)
75854-308-30
Product NDC
75854-308
11-digit billing NDC
75854030830
NCPDP billing unit
EA — each (per item)
UNII
PQ6CK8PD0R, 1C6V77QF41, WR1WPI7EW8, 935E97BOY8, 68Y4CF58BV, P6YC3EG204 +6 more
UPC
0375854308306
SPL Set ID
1076ba9a-0168-492f-ba9b-99fa02186092
Established class (EPC)
Vitamin C; Vitamin D; Vitamin B12
Chemical class
Ascorbic Acid; Vitamin D; Vitamin B 12
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2013-09-17
Route
ORAL
Dosage form
CAPSULE, GELATIN COATED
Substance
ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; LACTIC ACID; DOCONEXENT
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
071464
GCN
35265
HICL code
040617
Ingredient (HICL)
Prenatal 69/Iron/Folate 6/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
PRENATE RESTORE SOFTGEL
FDB brand name
Prenate Restore
Legend status
Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
- GSN (GCN sequence number): 071464
- GCN: 35265
- HICL (First Databank): 040617
- AHFS class code: 20:04.04.00
Why two NDCs?
The FDA registers this code as 75854-308-30 — 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 → 75854-0308-30. 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 PRENATE RESTORE SOFTGEL Ingredient Prenatal 69/Iron/Folate 6/Dha
🧪 What is this product?
Prenate Restore is an oral gelatin capsule containing a combination of vitamins and minerals. The product includes vitamin C, vitamin D, vitamin E, folic acid, vitamin B6, vitamin B12, and biotin, which are typically used as nutritional supplements. It also contains calcium, iron, magnesium, and an ingredient called doconexent. This is an unapproved drug product and has not been reviewed or approved by the FDA.
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 ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent?
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 | $1.55 | $46.50 / 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 Q1 2026
- 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 |
|---|---|---|---|---|
| 75854-0308-30 You're viewing this Main listing | 30 CAPSULE, GELATIN COATED in 1 BOTTLE | 2013-09-17 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| PRENATE Restore 85 mg/1; 1000 [iU]/1; 10 [iU]/1; 1 mg/1; 25 mg/1; 12 ug/1; 500 ug/1; 155 mg/1; 27 mgthis 75854-0308-30 | 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
🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 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 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 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 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 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesOTHER INGREDIENTS: Beeswax, palm shortening, and soy lecithin. Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide).
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 marketedSep 2013
Product typeHuman Prescription Drug
Portfolio13 products on file
More NDCs from Avion Pharmaceuticals, LLC labeler code 75854
- Prenate Chewable calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, levomefolate glucosamine, pyridoxine hydrochloride, cyanocobalamin, biotin and blueberry 500 mg; 7.5 ug; 50 mg; 12.5 ug; 400 ug; 10 mg; 125 ug; 280 ug; 25 mg; 600 ug Tablet, Chewable NDC 75854-306-30
- 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, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent 40 [iU]/1; 90 mg; 155 mg; 400 [iU]/1; 25 ug; 300 mg; 18 mg; 1 mg; 50 mg Capsule, Gelatin Coated NDC 75854-312-30
- Prenate Essential ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icos 10 [iU]/1; 5-METHYLTETRAHYDROFOLIC ACID 600 ug; 90 mg; 280 ug; 155 mg; 220 [iU]/1; 13 ug; 300 mg; 18 mg 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, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin 40 [iU]/1; 2600 [iU]/1; 5-METHYLTETRAHYDROFOLIC ACID 600 ug; 75 mg; 330 ug; 155 mg; 600 [iU]/1; 1.5 mg; 13 ug Tablet, Coated NDC 75854-314-30
- Prenate Mini ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry 10 [iU]/1; 60 mg; 280 ug; 80 mg; 1000 [iU]/1; 13 ug; 350 mg; 9 mg; 400 ug; 9 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
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
⚠️ Warnings
🤒 Adverse Reactions
📦 How Supplied / Storage and Handling
📦 Storage and Handling
🧪 Inactive Ingredients
📋 Description
⚠️ Precautions
📄 Package Label / Principal Display Panel
🚨 Boxed Warning ▾
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 ▾
INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and nonlactating mothers.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.
⛔ Contraindications ▾
CONTRAINDICATIONS: PRENATE ® Restore is contraindicated in patients with a known hypersensitivity to any of the ingredients.
⚠️ Warnings ▾
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
🤒 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 (75854-308-30). 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.]
🧪 Inactive Ingredients ▾
OTHER INGREDIENTS: Beeswax, palm shortening, and soy lecithin. Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide).
📋 Description ▾
DESCRIPTION: PRENATE ® Restore is a prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other. 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. Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results.
Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 30 Softgel label 75854-308-30 PRENATE ® Restore Rx postnatal vitamin with probiotics, DHA and chelated iron Rx Only Dietary Supplement 30 Softgels Avion PHARMACEUTICALS Bottle Label
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 – 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
11
Units reimbursed last 4 qtrs
338
Gross reimbursed last 4 qtrs
$523.89
Avg / prescription
$47.63
Avg / unit
$1.5500
Latest quarter Q1 2026
11Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 11 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.13.1
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 PRENATE Restore (this brand).
Top reported reactions
Reporter sex
Female · 100%
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 | ✓ Available |
| 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.