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Opium Tincture Deodorized Morphine 10 mg/mL Tincture, 473 mL — NDC 42799-0217-02 package photo

Opium Tincture Deodorized Morphine 10 mg/mL Tincture, 473 mL

by Edenbridge Pharmaceuticals, LLC · 473 mL in 1 BOTTLE, PLASTIC (42799-217-02)
NDC 42799-0217-02
🏷️ FDA NDC (as labeled) 42799-217-02 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes2 compare ↓
Also comes in: 118 ml 42799-0217-01
Rx only On market CII
🗂️ Data synced 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

Past resolved recalls for this product (1)
Class III · Oct 20, 2023 · Terminated — Subpotent Drug (Edenbridge Pharmaceuticals, LLC) · FDA recall D-0080-2024

🆔 Identity & classification

FDA NDC (as labeled) 42799-217-02
Product NDC 42799-217
11-digit billing NDC 42799021702
NCPDP billing unit ML — per mL (volume)
RxCUI 830196
UNII 76I7G6D29C
SPL Set ID e2a5697a-cc41-4cf1-b3a8-59b0268740d7
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 2010-07-15
Route ORAL
Dosage form TINCTURE
Substance MORPHINE
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
Why two NDCs? The FDA registers this code as 42799-217-02 — 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 → 42799-0217-02. 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.

🏭 Manufacturer & labeler

LabelerEdenbridge Pharmaceuticals, LLC
Labeler code42799
First marketedJul 2010
DEA scheduleCII
Product typeHuman Prescription Drug
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.

🩺 Clinical

Label name OPIUM TINCTURE 10 MG/ML Ingredient Opium Tincture
📗 Our plain-language guide HelloPharmacist
  • Morphine is typically prescribed only when your pain is severe enough that other options — like non-opioid medicines or weaker opioid combinations — haven't worked or aren't expect...
  • Why is my doctor prescribing morphine instead of something milder?
  • No — and this is one of the most important rules with morphine. Alcohol combined with morphine can push your morphine blood levels to life-threatening highs. This means no wine, be...
  • Can I drink alcohol while taking morphine?
📖 Read our full Morphine guide →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 118 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Opium Tincture Deodorized 1 g/100mL 62559-0153-04 ANI 118 ml $2.850 — Availability likely —
Opium Tincture Deodorized 10 mg/mLthis 42799-0217-02 Edenbridge 473 ml — — FDA listed —
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

🏛️
2010
On the market since
Jul 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
118 ml42799-0217-01 52 Rx · $16,920
473 ml this page42799-0217-02 No Medicaid data
Drug total (last 4 qtrs): 52 Rx · 5,101 units · $16,920 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
42799-0217-01 118 mL in 1 BOTTLE, PLASTIC (42799-217-01) $2.85 / mL $336.26 2010-07-15 Active
42799-0217-02 You're viewing this 473 mL in 1 BOTTLE, PLASTIC (42799-217-02) — — 2010-07-15 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 42799-0217-02?
NDC 42799-0217-02 contains 473 mL — 473 ml in 1 bottle, plastic.
What is the difference between NDC 42799-0217-02 and NDC 42799-0217-01?
Both are Opium Tincture Deodorized Morphine 10 mg/mL Tincture — the drug itself is identical. NDC 42799-0217-02 is the 473 mL package, while NDC 42799-0217-01 is the 118 ml package.
What NDC number is used to bill for this package of Opium Tincture Deodorized Morphine 10 mg/mL Tincture?
Bill NDC 42799-0217-02 — the 11-digit billing format is 42799021702. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 42799-217-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 42799-0217-02, written without dashes as 42799021702. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 42799-0217-02, the first segment (42799) is the labeler code FDA assigned to Edenbridge Pharmaceuticals, LLC; the middle segment (0217) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Edenbridge Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 118 ml (42799-0217-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Edenbridge 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.

📄 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
🎯 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 17 words ▾

ADVERSE REACTIONS Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.

🆘 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 53 words ▾

HOW SUPPLIED Opium Tincture, USP (Deodorized), is supplied as: NDC 42799-217-01 Bottles of 4 fl oz NDC 42799-217-02 Bottles of 16 fl oz Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP). Manufactured for: Edenbridge Pharmaceuticals, LLC DBA Dexcel Pharma USA Parsippany, NJ 07054 USA 877-381-3336 Rev. 09/2024 1000009908-00

📋 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42799-0208-01 · Edenbridge 42799-0405-01 · Edenbridge →
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.