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Opium Tincture Deodorized morphine 1 g/100mL Solution, 118 mL — NDC 62559-0153-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Opium Tincture Deodorized morphine 1 g/100mL Solution, 118 mL — NDC 62559-153-04 (Billing 62559-0153-04)

by ANI Pharmaceuticals, Inc. · 118 mL in 1 BOTTLE

This is a package of 118 mL of Opium Tincture Deodorized morphine 1 g/100mL Solution from ANI Pharmaceuticals, Inc., marketed since Feb 2011 and currently FDA-listed; retail pharmacies pay about $2.86 per mL (NADAC). It is this product's only package size.

NDC 62559-0153-04
🏷️ FDA NDC (as labeled) 62559-153-04 billing pads the product segment with a zero
Rx only On market CII ⇄ 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 62559-153-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62559 labeler · 153 product · 04 package
Package marketed since
Feb 25, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
118 mL per package
Barcode (UPC)
0362559153041
Medicaid fills, this package
414 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) 62559-153-04
Product NDC 62559-153
11-digit billing NDC 62559015304
NCPDP billing unit ML — per mL (volume)
RxCUI 830196
UNII 76I7G6D29C
UPC 0362559153041
SPL Set ID 674a969a-707d-41a9-b7c3-b90cbf2909e3
Established class (EPC) Opioid Agonist
Mechanism of action Full Opioid Agonists
DEA schedule CII
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-02-25
Route ORAL
Dosage form SOLUTION
Substance MORPHINE

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

GPI-14 47100030201505
GPI class Opium
GCN Seq No 004261
GCN 16471
HICL code 038961
Ingredient (HICL) Opium Tincture
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name OPIUM TINCTURE 10 MG/ML
FDB brand name Opium Tincture
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004261
  • GCN: 16471
  • GPI-14 (Medi-Span): 47100030201505
  • HICL (First Databank): 038961
  • AHFS class code: 28:08.08.00
  • RxCUI (RxNorm): 830196
Why two NDCs? The FDA registers this code as 62559-153-04 — 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 → 62559-0153-04. 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 Antipropulsives class.

Drug family (ATC) Antipropulsives, Natural opium alkaloids
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 OPIUM TINCTURE 10 MG/ML Ingredient Opium Tincture
📗 Our plain-language guide HelloPharmacist
  • Morphine treats severe pain when other treatments haven't worked or aren't suitable. Some forms are short-acting, and others are long-acting for around-the-clock pain. Your prescri...
  • Follow your label exactly. Extended-release capsules and tablets must be swallowed whole, never crushed or chewed, because that can release a dangerous dose at once. For liquid, us...
  • No. Alcohol can raise morphine levels and cause a fatal overdose. Avoid products containing alcohol, and check with me before taking other sedating medicines like sleep aids or anx...
  • Constipation, nausea, drowsiness, and dizziness are most common. Call for help right away if you have slow or shallow breathing, extreme sleepiness, fainting, or an allergic reacti...
📖 Read our full Morphine guide →

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 mLPer package
Retail pharmacies payNADAC · weekly $2.858 $337.20 / 118 ml
Medicaid paysCMS SDUD · 12 mo $3.21 $379.32 / 118 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Nov 2021 Sep 2022 Mar 2026 Sep 2026 $3.307 $2.536
▼ Down 14% over the last 17 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
62559-0153-04 You're viewing this Main listing 118 mL in 1 BOTTLE 2011-02-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Opium Tincture Deodorized 10 mg/mL 42799-0217-01 Edenbridge 118 ml $2.858 — Availability likely —
Opium Tincture Deodorized 1 g/100mLthis 62559-0153-04 ANI 118 ml $2.858 — Availability likely —
Opium Tincture Deodorized 10 g/1000mL 63629-1965-01 Bryant 118 ml — — FDA listed —
Opium 1 g/100mL 64950-0258-11 Genus 118 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Morphine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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.

2 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

LabelerANI Pharmaceuticals, Inc.
Labeler code62559
First marketedFeb 2011
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio299 products on file

More NDCs from ANI Pharmaceuticals, Inc. labeler code 62559

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 12 words ▾

INDICATIONS AND USAGE Opium tincture is useful for the treatment of diarrhea.

⏱️ Dosage and Administration 14 words ▾

DOSAGE AND ADMINISTRATION Usual Adult Dose – 0.6 mL orally 4 times a day.

⛔ Contraindications 30 words ▾

CONTRAINDICATIONS This preparation is not recommended for use in children. It should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract.

⚠️ Warnings 31 words ▾

WARNINGS Addiction can result from opium usage. Opium preparations should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.

🤒 Adverse Reactions 34 words ▾

ADVERSE REACTIONS Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Signs and Symptoms – Symptoms of toxicity are those of morphine and alcohol, such as nausea, vomiting, miosis, cool and clammy skin, respiratory and CNS depression, bradycardia, hypotension, and skeletal muscle flaccidity. Noncardiogenic pulmonary edema may develop after opioid overdose and monitoring of heart filling pressure may be helpful. Ethanol has been demonstrated to cause hypoglycemia in children or adults with limited glycogen stores.

In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur. Treatment – To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR).

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Initial management of opioid overdose should emphasize establishment of a secure airway and support of ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, blood glucose, etc.

Naloxone antagonizes most effects of opioids. Protect the airway as naloxone may induce vomiting. Since naloxone has a shorter duration of action than opioids, repeated doses may be needed.

In patients who abuse opioids chronically, a withdrawal syndrome may be manifest on administration of naloxone. This may include yawning, tearing, restlessness, sweating, dilated pupils, piloerection, vomiting, diarrhea, and abdominal cramps. This syndrome usually abates quickly as the effect of naloxone dissipates.

Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Since opium tincture can delay gastric emptying, evacuation of the stomach may be beneficial.

Safeguard the patient’s airway when employing gastric emptying or charcoal. Monitor for and treat hypoglycemia. The use of forced diuresis, peritoneal dialysis, hemodialysis or charcoal hemoperfusion has not been established to be beneficial.

🧬 Clinical Pharmacology 170 words ▾

CLINICAL PHARMACOLOGY The opiates act by enhancing tone in the long segments of longitudinal muscle and by inhibiting propulsive contraction of both circular and longitudinal muscles. Clinical evidence indicates that the analgesic activity of opium preparations is due to their morphine content. Relatively small doses that do not produce significant analgesia are effective in controlling diarrhea.

The papaverine content of the mixed alkaloids is too small to have demonstrable spasmolytic activity. Following oral administration, morphine is well absorbed from the gastrointestinal tract. It is rapidly metabolized following oral administration, however, and plasma levels of unconjugated morphine are lower than those achieved after parenteral administration.

Like other narcotic analgesics, opium preparations are metabolized in the liver. Morphine undergoes conjugation with glucuronic acid at the 3-hydroxyl group. Secondary conjugation may also occur at the 6-hydroxyl group to form the 3,6-diglucuronide.

Morphine is excreted in the urine mainly as morphine-3-glucuronide and smaller amounts of morphine-3,6-diglucuronide and unchanged drug. Approximately 75% of a dose of morphine is excreted in the urine within 48 hours.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Opium Tincture, USP (Deodorized), is supplied as: NDC 62559-153-04 Bottles of 4 fl oz Dispense in tightly closed containers. Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP). Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9424 Rev 01/25 ani

📋 Description 77 words ▾

DESCRIPTION Opium Tincture, USP (Deodorized), is for oral administration. It is freed from unpleasant odor or nauseating substances by “denarcotization” with a petroleum distillate. Opium tincture is a clear, reddish-brown hydroalcoholic solution.

Each 100 mL contains 1 g of anhydrous morphine (represents the equivalent of 10 g of Powdered Opium, USP), alcohol, 19%, and water. Opium has a very characteristic odor and a very bitter taste. The opiates are the most effective and prompt-acting nonspecific antidiarrheal agents.

⚠️ Precautions 176 words ▾

PRECAUTIONS General – Opium should be used with caution in the elderly, in debilitated individuals, and in patients with increased intracranial pressure, cerebral arteriosclerosis, hepatic cirrhosis or liver insufficiency, gastrointestinal hemorrhage, myxedema, emphysema, and bronchial asthma. Drug Interactions – When preparations containing opium are administered in combination with other drugs, the cautions applicable to each ingredient should be borne in mind. Reduced dosage is indicated in poor-risk patients, in the very young or very old patient, and in those who are receiving other central-nervous system depressants.

Usage in Pregnancy – Animal reproduction studies have not been conducted with Opium Tincture, USP (Deodorized). It is also not known whether Opium Tincture, USP (Deodorized), can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Opium Tincture, USP (Deodorized), should be given to a pregnant woman only if clearly needed.

Nursing Mothers – Caution should be exercised when Opium Tincture, USP (Deodorized), is administered to a nursing woman. Usage in Children – Safety and effectiveness in children have not been established. See CONTRAINDICATIONS .

🔒 Drug Abuse and Dependence 19 words ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance – Opium Tincture, USP (Deodorized), is a Schedule II drug. See WARNINGS .

📄 Package Label / Principal Display Panel 23 words ▾

Package/Label Display Panel Opium Tincture USP (Deodorized), 10 mg/mL of anhydrous morphine, CII NDC 62559-153-04 Rx only 118 mL (4 fl. oz.) 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
414
Units reimbursed last 4 qtrs
58.2K
Gross reimbursed last 4 qtrs
$187K
Avg / prescription
$451.67
Avg / unit
$3.2146
Latest quarter Q1 2026
107Rx
Medicaid pays / mL
$3.2146
gross reimbursed
vs
NADAC / mL
$2.8576
acquisition cost
=
Spread
+$0.3570
+12% vs cost
What Medicaid paid per mL (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 ⓘ
54% FFS 46% MCO
Fee-for-service · 225 Rx Managed care · 189 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,000 units · 38.4 per 100k residents 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: 28,713 units · 147 per 100k residents NY Vermont: 828 units · 128 per 100k residents 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: 1,924 units · 28.0 per 100k residents IN Ohio: no data reported OH Pennsylvania: 1,181 units · 9.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 8,897 units · 127 per 100k residents MA California: 8,722 units · 22.4 per 100k residents 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: 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: 4,004 units · 37.0 per 100k residents 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: no data reported TX Florida: 900 units · 4.0 per 100k residents FL
Units reimbursed · per 100k residents
4.0147
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 147 /100k
2 Vermont 128 /100k
3 Massachusetts 127 /100k
4 Washington 38.4 /100k
5 North Carolina 37.0 /100k
6 Indiana 28.0 /100k
7 California 22.4 /100k
8 Pennsylvania 9.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Morphine tincture — the ingredient across all brands.

Top reported reactions

Diarrhoea2
Abdominal Pain1
Asthenia1
Chills1
Dehydration1
Epistaxis1
Gastrointestinal Haemorrhage1

Reporter sex

3 reports
Male · 100%

Serious outcomes

Hospitalization3
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) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ANI Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ANI Pharmaceuticals, Inc. 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.
← 62559-0151-16 · ANI 62559-0157-10 · ANI →
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.