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Ferralet 90 iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium 90 mg; 1 mg; 12 ug; 120 mg; 50 mg Tablet, Film Coated, 90-count — NDC 0178-0089-90 (Billing 00178-0089-90)

by Mission Pharmacal Company · 90 TABLET, FILM COATED in 1 BOTTLE

This is a package of 90 tablets of Ferralet 90 iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium 90 mg; 1 mg; 12 ug; 120 mg; 50 mg Tablet, Film Coated from Mission Pharmacal Company, no longer marketed (first marketed Feb 2010), no longer in the FDA NDC Directory; retail pharmacies pay about $2.18 per tablet (NADAC). It is this product's only package size.

NDC 00178-0089-90
🏷️ FDA NDC (as labeled) 0178-0089-90 billing pads the labeler segment with a zero
Rx only Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0178-0089-90 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0178 labeler · 0089 product · 90 package
Package marketed since
Jun 23, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
90 EA per package
Barcode (UPC)
0301780089903
Medicaid fills, this package
4,669 prescriptions in the last four reported quarters
FDA record last changed
Aug 27, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2017. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0178-0089-90
Product NDC 0178-0089
11-digit billing NDC 00178008990
NCPDP billing unit EA — each (per item)
RxCUI 836268, 836270
UNII E1UOL152H7, 935E97BOY8, P6YC3EG204, PQ6CK8PD0R, F05Q2T2JA0
UPC 0301780089903
SPL Set ID 0be2918e-55b3-4c66-aba0-09099a1c7770
Established class (EPC) Vitamin B12; Vitamin C
Chemical class Vitamin B 12; Ascorbic Acid
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2017)
Marketing start 2010-02-04
Route ORAL
Dosage form TABLET, FILM COATED
Substance IRON; FOLIC ACID; CYANOCOBALAMIN; ASCORBIC ACID; DOCUSATE SODIUM

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

GPI-14 82995006350330
GPI class Ferralet 90
GCN Seq No 066264
GCN 28505
HICL code 036940
Ingredient (HICL) Iron Carb,Gl/Fa/B12/C/Docusate
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 FERRALET 90 TABLET
FDB brand name Ferralet 90
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 066264
  • GCN: 28505
  • GPI-14 (Medi-Span): 82995006350330
  • HICL (First Databank): 036940
  • AHFS class code: 20:04.04.00
  • RxCUI (RxNorm): 836268
Why two NDCs? The FDA registers this code as 0178-0089-90 — a 4-4-2 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 labeler segment → 00178-0089-90. 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.

RxNorm drug class

This medicine belongs to the Vitamin B12 class.

Pharmacologic class Vitamin B12
Drug family (ATC) Vitamin B12 (cyanocobalamin and analogues)
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FERRALET 90 TABLET Ingredient Iron Carb,Gl/Fa/B12/C/Docusate
🧪 What is this product?

Ferralet 90 is an oral tablet containing iron, folic acid, vitamin B12 (cyanocobalamin), vitamin C (ascorbic acid), and docusate sodium. Iron, folic acid, and vitamin B12 are typically used in combination products intended to support red blood cell formation and treat or prevent certain types of anemia and nutritional deficiencies. Vitamin C is commonly included to enhance iron absorption. Docusate sodium is a stool softener typically used to help prevent constipation, which can be a side effect of iron supplements. This product is marketed without an approved FDA application.

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 $2.185 $196.61 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $2.36 $212.72 / 90 tablets
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
Aug 2021 Jan 2026 May 2026 Sep 2026 $2.332 $2.155
▼ Down 6% over the last 13 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
00178-0089-90 You're viewing this Main listing 90 TABLET, FILM COATED in 1 BOTTLE 2010-06-23 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ferralet 90 90 mg/1; 1 mg/1; 12 ug/1; 120 mg/1; 50 mgthis 00178-0089-90 Mission 90 tablets $2.185 — Discontinued —
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

🏛️
2010
On the market since
Feb 2010
📍
2026
Currently FDA-listed
16 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.

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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII 9B9691B2N9
    Magnesium silicate is a mineral compound used in tablets and capsules as a glidant and anti-caking agent. It helps powder ingredients flow smoothly during manufacturing and prevents clumping in the final product.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.

9 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

LabelerMission Pharmacal Company
Labeler code00178
First marketedFeb 2010
Product typeHuman Prescription Drug
Portfolio26 products on file
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 39 words ▾

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

🎯 Indications and Usage 40 words ▾

INDICATIONS AND USAGE Ferralet ® 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs.

⏱️ Dosage and Administration 12 words ▾

DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

⚠️ Warnings 23 words ▾

WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

🤒 Adverse Reactions 40 words ▾

ADVERSE REACTIONS Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 40 words ▾

Geriatric Use Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

🆘 Overdosage 37 words ▾

OVERDOSAGE Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

🧬 Clinical Pharmacology 143 words ▾

CLINICAL PHARMACOLOGY Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis.

Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids.

Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B 12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Ferralet ® 90 (NDC 0178-0089-90) is a green, modified rectangle shaped, film-coated tablet, debossed with "F6" on one side and blank on the other, and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature.)

📋 Description 66 words ▾

DESCRIPTION Each green film-coated tablet for oral administration contains: Iron (Carbonyl iron, ferrous gluconate) 90 mg Folic Acid 1 1 mg Vitamin B 12 (Cyanocobalamin) 12 mcg Vitamin C (Ascorbic acid) 120 mg Docusate sodium 50 50 mg Inactive Ingredients: Povidone, croscarmellose sodium, acrylic resin, color added, magnesium stearate, FD&C Yellow No. 5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin A palmitate, ethyl vanillin.

⚠️ Precautions 219 words ▾

PRECAUTIONS General Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.

The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet ® 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

This product contains FD&C Yellow No. 5 (tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No.

5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Folic Acid Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

📄 Patient Package Insert ~2 min read ▾

Ferralet ® 90 90 mg Dual-Iron Delivery RX ONLY THERAPEUTIC GUIDELINES FOR THE PATIENT Some facts you should know about Iron Deficiency Anemia Iron Deficiency Anemia, or IDA, is a common type of anemia. It's a condition in which blood lacks an adequate supply of healthy red blood cells. These cells carry oxygen to tissues.

It is oxygenated blood that gives your body energy and your skin a healthy color. As the name suggests, Iron Deficiency Anemia results from insufficient iron. Your body needs iron to make a substance called hemoglobin.

It's the hemoglobin in red blood cells that enables them to carry oxygen. What causes IDA? There are many causes of IDA.

These include: A diet consistently low in iron Blood loss due to heavy menstrual bleeding Poor iron absorption from food due to intestinal surgery or diseases of the intestine Pregnancy (when the need for iron increases significantly) Women in general are at higher risk of IDA, not only because they lose blood during menstruation but also because their bodies store less iron. How common is it? IDA is a common nutritional deficiency, with women most widely affected.

Up to 20% of women have IDA. What are the symptoms? Some of the symptoms most commonly associated with IDA are fatigue, weakness, and headache.

Symptoms may also include light-headedness, pale skin, shortness of breath, and cold hands and feet, among others. As the body becomes more deficient in iron and anemia worsens, the symptoms worsen as well. How is IDA diagnosed?

A diagnosis is made primarily through blood tests. The doctor checks your hematocrit, the percentage of your blood volume made up of red blood cells and hemoglobin. A lower than normal hemoglobin level indicates anemia.

Also, blood tests for IDA typically include a measurement of ferritin, a protein that helps store iron in your body. When the level of ferritin is low, usually the level of iron is, too. If a patient tests positive for IDA, additional tests may be ordered to identify an underlying cause.

Does IDA lead to health complications? Mild cases of IDA usually don't cause complications. However, left untreated, IDA can increase in severity and contribute to serious health problems.

For example, it may lead to a rapid or irregular heartbeat, a complicated pregnancy that can put the mother at risk for a premature delivery or low-birth-weight baby, and delayed growth in infants and children. The good news is that, because IDA is easily treatable, its potential health consequences are generally avoidable. How is IDA treated?

It's essential to increase the amount of iron in your diet. Foods rich in iron include meat, fish, poultry, and whole grain breads. However, in most cases of IDA, diet alone isn't enough to correct the problem.

Iron supplementation is usually needed for several months. Your doctor has prescribed Ferralet ® 90, a safe and effective iron supplement to help restore your body's iron to normal levels. Plus, it offers the convenience of once-daily dosing.

Together with an iron-rich diet, taking Ferralet ® 90 every day can make a big difference in helping restore your body's iron, and with it your energy and overall feeling of well-being.

📄 Package Label / Principal Display Panel 27 words ▾

PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Label NDC 0178-0089-90 Rx Only Ferralet ® 90 90 mg Dual-Iron Delivery 90 Coated Tablets MISSION ® PHARMACAL 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
4.7K
Units reimbursed last 4 qtrs
149.3K
Gross reimbursed last 4 qtrs
$352.8K
Avg / prescription
$75.56
Avg / unit
$2.3635
Latest quarter Q1 2026
1KRx
Medicaid pays / ea
$2.3635
gross reimbursed
vs
NADAC / ea
$2.1846
acquisition cost
=
Spread
+$0.1789
+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 ⓘ
90% MCO
Fee-for-service · 484 Rx Managed care · 4,185 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: 2,305 units · 204 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported 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: 12,627 units · 349 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: no data reported 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: 134,326 units · 440 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
204440
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 Texas 440 /100k
2 Connecticut 349 /100k
3 Montana 204 /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.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application No longer marketed (per FDA listing data)

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Mission Pharmacal Company 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.