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Cupric Chloride .4 mg/mL Injection — NDC 70069-0506-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cupric Chloride .4 mg/mL Injection — NDC 70069-506-25 (Billing 70069-0506-25)

by Somerset Therapeutics, LLC · 25 VIAL, PLASTIC in 1 CARTON / 10 mL in 1 VIAL, PLASTIC

This is a package of Cupric Chloride .4 mg/mL Injection from Somerset Therapeutics, LLC, marketed since May 2024 and currently FDA-listed. It is this product's only package size.

NDC 70069-0506-25
🏷️ FDA NDC (as labeled) 70069-506-25 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 70069-506-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70069 labeler · 506 product · 25 package
Package marketed since
May 14, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0370069506011
Medicaid fills, this package
4,894 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70069-506-25
Product NDC 70069-506
11-digit billing NDC 70069050625
NCPDP billing unit ML — per mL (volume)
RxCUI 204536
UNII S2QG84156O
UPC 0370069506011
Application # ANDA216113
SPL Set ID 361d30f2-3c97-4a6c-b252-7fa864d0a625
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-14
Route INTRAVENOUS
Dosage form INJECTION
Substance CUPRIC CHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 79900010102010
GCN Seq No 001687
GCN 05160
HICL code 000753
Ingredient (HICL) Cupric Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3M
Therapeutic class — specific (HIC3) Mineral Replacement, Miscellaneous
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name CUPRIC CHLORIDE 4 MG/10 ML VL
FDB brand name Cupric Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001687
  • GCN: 05160
  • GPI-14 (Medi-Span): 79900010102010
  • HICL (First Databank): 000753
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 204536
Why two NDCs? The FDA registers this code as 70069-506-25 — 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 → 70069-0506-25. 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 CUPRIC CHLORIDE 4 MG/10 ML VL Ingredient Cupric Chloride

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $81.52 $2,038.06 / 25 vials
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70069-0506-25 You're viewing this Main listing 25 VIAL, PLASTIC in 1 CARTON / 10 mL in 1 VIAL, PLASTIC 2024-05-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Copper .4 mg/mL 00409-4092-01 Hospira, 25 vials — AP FDA listed —
Cupric Chloride .4 mg/mL 51754-0103-03 Exela 10 vials — AP FDA listed —
Cupric Chloride .4 mg/mLthis 70069-0506-25 Somerset 25 vials — AP FDA listed —
Cupric Chloride .4 mg/mL 72603-0351-25 Northstar 25 vials — AP FDA listed —
Cupric Chloride .4 mg/mL 72819-0234-99 Archis 25 vials — AP FDA listed —
Cupric Chloride .4 mg/mL 80830-2301-05 Amneal 25 vials — — FDA listed —
Cupric Chloride .4 mg/mL 84897-0013-25 Renova 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

4 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

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA216113 (ANDA)
Labeler code70069
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio184 products on file

More NDCs from Somerset Therapeutics, LLC labeler code 70069

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

INDICATIONS AND USAGE Cupric chloride injection 0.4 mg/mL is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Cupric Chloride Injection contains 0.4 mg of copper per mL and is administered intravenously only after dilution. The additive should be diluted in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage of copper is 0.3 to 0.5 mg/day.

For pediatric patients, the suggested additive dosage of copper is 20 mcg/kg/day (0.05 mL/kg/day) up to a maximum of 500 mcg/day. This product is not appropriate for patients weighing less than 4 kg due to the inability to measure the appropriate amount of the product. Do not administer Cupric Chloride Injection intramuscularly because the acidic pH of the solution may cause considerable tissue irritation.

Cupric Chloride Injection should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. The solution contains no preservatives; discard the unused portion immediately after the admixture procedure is completed. Cupric Chloride Injection should be inspected visually for particulate matter and discoloration prior to administration.

Do not use unless the solution is clear, and the seal is intact. Cupric ion may degrade ascorbic acid in TPN solutions. In order to avoid this loss of ascorbate, multivitamin additives should be added to TPN solutions immediately prior to infusion.

Alternatively, the multivitamin additive may be added to one container of TPN solution, followed by copper in a subsequent container.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Cupric Chloride Injection is contraindicated in patients with hypersensitivity to copper (see WARNINGS: Hypersensitivity Reactions ).

⚠️ Warnings ~1 min read ▾

WARNINGS Hepatic Accumulation Cupric Chloride Injection is primarily eliminated in the bile and excretion is decreased in patients with cholestasis and/or cirrhosis. Hepatic accumulation of copper has been reported in autopsies of patients receiving long-term parenteral nutrition containing copper at dosages higher than recommended. Administration of copper to patients with cholestasis and/or cirrhosis may cause hepatic accumulation of copper.

Administration of copper to patients with Wilson disease, an inborn error of copper metabolism with a defect in hepatocellular copper transport, may cause both increased hepatic accumulation of copper and aggravation of the underlying hepatocellular degeneration. For patients with cholestasis, biliary dysfunction, or cirrhosis, monitor hepatic and biliary function during long-term administration of Cupric Chloride Injection. If a patient develops signs or symptoms of hepatobiliary disease during the use of Cupric Chloride Injection, obtain serum concentrations of copper and ceruloplasmin, and adjust the dose as indicated (see PRECAUTIONS: Hepatic Impairment ).

Hypersensitivity Reactions Postmarket safety reporting has identified copper hypersensitivity in women receiving copper-containing intrauterine devices, providing evidence that patients may experience hypersensitivity reactions when exposed to this metal. If hypersensitivity reactions (e.g., pruritis, angioedema, dyspnea, rash, urticaria) occur in patients receiving Cupric Chloride Injection in parenteral nutrition, discontinue the product, and initiate appropriate medical treatment (see CONTRAINDICATIONS ). Aluminum Toxicity This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

🤒 Adverse Reactions 4 words ▾

ADVERSE REACTIONS None known.

🆘 Overdosage 89 words ▾

OVERDOSAGE Acute copper toxicity has been reported in patients with oral, intravenous, or subcutaneous administration. Clinical manifestations included metallic taste, nausea, vomiting, diarrhea, abdominal pain, neurological signs, such as encephalopathy, and multi-organ failure involving kidney, liver, blood, and cardiovascular systems, which may be fatal. Chelating agents, such as D-penicillamine, can be used for treatment of acute toxicity.

Long-term administration of parenteral copper above the recommended dosage may result in significant accumulation of copper in the liver, brain, and other tissues with possible organ damage (see WARNINGS: Hepatic Accumulation ).

🧬 Clinical Pharmacology 160 words ▾

CLINICAL PHARMACOLOGY Copper is an essential nutrient which serves as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. Copper also helps maintain normal rates of red and white blood cell formation. Providing copper during TPN helps prevent development of the following deficiency symptoms: Leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation, secondary iron deficiency and osteoporosis.

Normal serum copper values range from 80 to 163 mcg/dl (mean, approximately 110 mcg/dl). The serum copper level at which deficiency symptoms appear is not precisely defined. In the plasma, about 7% of copper is bound to albumin and amino acids.

In the liver, about 93% of copper is bound to ceruloplasmin and released to the serum. The daily turnover of copper through ceruloplasmin is approximately 0.5 mg. Cupric Chloride Injection is primarily excreted through the bile and into the gastrointestinal tract where it is not reabsorbed.

Copper is also eliminated through the kidneys.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/ mL is available in packages as follows: NDC Strength Packaged 70069- 506 -25 4 mg/10 mL (0.4 mg/mL) 25 vials of 10 mL Store at 20 to 25°C (68 to 77°F). [See USP Contro l led Room Temperature.]

📋 Description 173 words ▾

DESCRIPTION Cupric chloride injection, USP 0.4 mg/ mL is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 1.07 mg cupric chloride, dihydrate and 9 mg sodium chloride. The solution contains no bacteriostat, antimicrobial agent or added buffer.

The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.327 mOsmol/mL (calc.). Cupric Chloride, USP is chemically designated cupric chloride, dihydrate (CuCl 2 • 2 H 2 O), a crystalline compound freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene.

The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Laboratory Tests Twice monthly serum assays for copper and/or ceruloplasmin are suggested for monitoring copper concentrations in long-term TPN patients. As ceruloplasmin is a cuproenzyme, ceruloplasmin assays may be depressed secondary to copper deficiency. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of cupric chloride injection 0.4 mg/mL have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cupric chloride injection 0.4 mg/mL is administered to a nursing woman. Pediatric Use The safety and effectiveness of Cupric Chloride Injection have been established in pediatric patients receiving parenteral nutrition (see DOSAGE AND ADMINISTRATION ).

Pregnancy Animal reproduction studies have not been conducted with cupric chloride. It is also not known whether cupric chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Cupric chloride should be given to a pregnant woman only if clearly indicated.

Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hepatic Impairment Copper is primarily excreted in the bile.

Excretion is decreased in patients with cholestasis and/or cirrhosis (see CLINICAL PHARMACOLOGY ). Hepatic accumulation of copper has been reported with long-term administration of parenteral nutrition at dosages higher than recommended (see WARNINGS: Hepatic Accumulation ). For patients with cholestasis or cirrhosis, monitor hepatic and biliary function during long-term administration of Cupric Chloride Injection.

If a patient develops signs or symptoms of hepatobiliary disease during use of Cupric Chloride Injection, obtain serum concentrations of copper and ceruloplasmin.

🔒 Drug Abuse and Dependence 6 words ▾

DRUG ABUSE AND DEPENDENCE None known.

📄 Package Label / Principal Display Panel 48 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70069-506-01 Rx only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION. Carton Label NDC 70069-506-25 Rx only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION. Image Image

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 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.9K
Units reimbursed last 4 qtrs
31.6K
Gross reimbursed last 4 qtrs
$2.58M
Avg / prescription
$526.21
Avg / unit
$81.5236
Latest quarter Q4 2025
1.4KRx
Fee-for-service vs managed care ⓘ
98% FFS
Fee-for-service · 4,785 Rx Managed care · 109 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: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 381 units · 9.0 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 879 units · 7.0 per 100k residents 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: 28,310 units · 72.7 per 100k residents CA Utah: no data reported UT Colorado: 1,988 units · 33.8 per 100k residents 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: no data reported 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: 32 units · 0.6 per 100k residents 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
0.672.7
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 California 72.7 /100k
2 Colorado 33.8 /100k
3 Oregon 9.0 /100k
4 Illinois 7.0 /100k
5 Alabama 0.6 /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
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 ✓ Available
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

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 Somerset Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Somerset Therapeutics, 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.
← 70069-0501-01 · Somerset 70069-0516-01 · Somerset →
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.