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Promethazine Hydrochloride 25 mg Suppository, 12 suppositories — NDC 31722-0041-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Promethazine Hydrochloride 25 mg Suppository, 12 suppositories — NDC 31722-041-31 (Billing 31722-0041-31)

by Camber Pharmaceuticals, Inc. · 2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK

This is a package of 12 suppositories of Promethazine Hydrochloride 25 mg Suppository from Camber Pharmaceuticals, Inc., marketed since Nov 2022 and currently FDA-listed; retail pharmacies pay about $2.03 per suppositorie (NADAC). It is this product's only package size.

NDC 31722-0041-31
🏷️ FDA NDC (as labeled) 31722-041-31 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 →

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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 31722-041-31 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
31722 labeler · 041 product · 31 package
Package marketed since
Nov 2, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
12 EA per package
Barcode (UPC)
0331722040310, 0331722041317
Medicaid fills, this package
15,817 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) 31722-041-31
Product NDC 31722-041
11-digit billing NDC 31722004131
NCPDP billing unit EA — each (per item)
RxCUI 992441, 992454
UNII R61ZEH7I1I
UPC 0331722040310, 0331722041317
Application # ANDA216446
SPL Set ID ba7d9e82-9b13-4607-b2f9-25e575b8c73b
Established class (EPC) Phenothiazine
Chemical class Phenothiazines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-02
Route RECTAL
Dosage form SUPPOSITORY
Substance PROMETHAZINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 41400020105210
GCN Seq No 003873
GCN 15001
HICL code 012014
Ingredient (HICL) Promethazine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 04:04.12.00
AHFS class Phenothiazine Derivatives
FDB label name PROMETHAZINE 25 MG SUPPOSITORY
FDB brand name Promethazine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003873
  • GCN: 15001
  • GPI-14 (Medi-Span): 41400020105210
  • HICL (First Databank): 012014
  • AHFS class code: 04:04.12.00
  • RxCUI (RxNorm): 992441
Why two NDCs? The FDA registers this code as 31722-041-31 — 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 → 31722-0041-31. 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 Phenothiazine class.

Pharmacologic class Phenothiazine
Drug family (ATC) Antihistamines for topical use, Phenothiazine derivatives
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 PROMETHAZINE 25 MG SUPPOSITORY Ingredient Promethazine Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats allergy symptoms like allergic rhinitis and hives, motion sickness, and nausea and vomiting around surgery. It is also used for sedation. Which uses apply depends on the...
  • Very likely. Drowsiness is its most common effect. Don't drive or use machinery until you know how it affects you, and avoid alcohol and other sedating medicines.
  • Not if the child is under 2. It can cause fatal slowed breathing in that age group. For children 2 and older, it needs real caution and the lowest effective dose, so only use it as...
  • Use an accurate measuring device, not a kitchen teaspoon, which can lead to overdose. I can give you an oral syringe or dosing cup and show you how to measure.
📖 Read our full Promethazine 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 eaPer package
Retail pharmacies payNADAC · weekly $2.035 $24.42 / 12 suppositories
Medicaid paysCMS SDUD · 12 mo $2.63 $31.58 / 12 suppositories
Medicare drug plans payPart D · Q2 2026 $3.08 $36.92 / 12 suppositories
Medicare Part B allowsASP · J8498 No ASP payment limit on file for J8498 this quarter.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $2.746 $1.840
▼ Down 26% 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.

Billing & reimbursement

FDA NDC (as labeled)31722-041-31
11-digit billing NDC31722-0041-31
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ8498
DescriptorANTIEMETIC DRUG, RECTAL/SUPPOSITORY, NOT OTHERWISE SPECIFIED
Billing units / pkg1 units
How the units are derivedThis package is 12 EA; the HCPCS unit is 1 EA, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
31722-0041-31 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK 2022-11-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Promethazine Hydrochloride 25 mgthis 31722-0041-31 Camber 12 suppositories $2.035 AB Availability likely —
Promethazine Hydrochloride 25 mg 45802-0759-30 Padagis 12 suppositories $2.035 AB Availability likely —
Promethegan 25 mg 00713-0526-10 Cosette 1000 suppositories — AB FDA listed —
Promethazine Hydrochloride 25 mg 43063-0060-02 PD-Rx 2 suppositories — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-2747-01 A-S 4 suppositories — AB FDA listed —
Promethegan 25 mg 55289-0928-02 PD-Rx 2 suppositories — AB FDA listed —
Promethazine Hydrochloride 25 mg 76420-0389-30 Asclemed 12 suppositories — AB 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

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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.

What it looks like

Color white
ShapeBullet
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.

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.

Manufacturer & labeler

LabelerCamber Pharmaceuticals, Inc.
Application holderANNORA PHARMA PRIVATE LTD
FDA applicationANDA216446 (ANDA)
Labeler code31722
First marketedNov 2022
Product typeHuman Prescription Drug
Portfolio603 products on file

More NDCs from Camber Pharmaceuticals, Inc. labeler code 31722

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 129 words ▾

INDICATIONS AND USAGE Promethazine hydrochloride suppositories are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism.

Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Promethazine hydrochloride suppositories are contraindicated for children under 2 years of age ( see WARNINGS–Black Box Warning and Use in Pediatric Patients ). Promethazine hydrochloride suppositories are for rectal administration only. Allergy The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary.

Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal.

For children, promethazine hydrochloride rectal suppositories, 12.5 to 25 mg, twice daily, may be administered. Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS -Use in Pediatric Patients ). The average effective dose of promethazine hydrochloride for the active therapy of nausea and vomiting in children or adults is 25 mg.

12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary.

Sedation This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine hydrochloride by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use Promethazine hydrochloride in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg promethazine hydrochloride with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Promethazine Hydrochloride Rectal Suppositories are contraindicated for children under 2 years of age.

⛔ Contraindications 60 words ▾

CONTRAINDICATIONS Promethazine hydrochloride suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

⚠️ Warnings ~2 min read ▾

WARNINGS PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. CNS Depression Promethazine hydrochloride suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.

The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride (see PRECAUTIONS−Information for Patients and Drug Interactions ). Respiratory Depression Promethazine hydrochloride suppositories may lead to potentially fatal respiratory depression.

Use of Promethazine hydrochloride suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold Promethazine hydrochloride suppositories may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression Promethazine hydrochloride suppositories should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS).

Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available.

There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. Use in Pediatric Patients PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES ARE CONTRAINDICAT… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 166 words ▾

ADVERSE REACTIONS Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular −Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic −Dermatitis, photosensitivity, urticaria. Hematologic −Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal −Dry mouth, nausea, vomiting, jaundice. Respiratory −Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS−Respiratory Depression .) Other −Angioneurotic edema.

Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS−Neuroleptic Malignant Syndrome .) Paradoxical Reactions Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride. Consideration should be given to the discontinuation of promethazine hydrochloride and to the use of other drugs if these reactions occur.

Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

🔄 Drug Interactions 193 words ▾

Drug Interactions CNS Depressants - Promethazine hydrochloride suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine hydrochloride. When given concomitantly with Promethazine hydrochloride suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.

Dosage must be individualized. Excessive amounts of promethazine hydrochloride relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine - Because of the potential for promethazine hydrochloride to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine hydrochloride suppositories overdose.

Anticholinergics - Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) - Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Promethazine hydrochloride suppositories.

🔄 Drug / Laboratory Test Interactions 55 words ▾

Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Pregnancy Tests Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test An increase in blood glucose has been reported in patients receiving promethazine hydrochloride.

🤰 Pregnancy 183 words ▾

Pregnancy Teratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine hydrochloride suppositories in pregnant women.

Promethazine hydrochloride suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Promethazine hydrochloride suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

🧒 Pediatric Use 51 words ▾

Pediatric Use PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS–Black Box Warning and Use in Pediatric Patients ). Promethazine hydrochloride suppositories should be used with caution in pediatric patients 2 years of age and older (see WARNINGS−Use in Pediatric Patients ).

🧓 Geriatric Use 109 words ▾

Geriatric Use Clinical studies of promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride suppositories and observed closely.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients.

Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms−dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms−may occur.

Treatment Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic.

Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected.

Note that any depressant effects of promethazine hydrochloride are not reversed by naloxone. Avoid analeptics which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated.

In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates.

Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.

🧬 Clinical Pharmacology 127 words ▾

CLINICAL PHARMACOLOGY Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent.

In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours.

Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

📦 How Supplied / Storage and Handling 91 words ▾

HOW SUPPLIED Promethazine Hydrochloride Rectal Suppositories USP are available in boxes of 12 as follows: 12.5 mg, white to off-white colored bullet shaped suppository wrapped in an Alu/PE shell. NDC 31722-040-31 25 mg, white to off-white colored bullet shaped suppository wrapped in an Alu/PE shell. NDC 31722-041-31 Store refrigerated between 2º to 8ºC (36º to 46ºF).

Dispense in well-closed container. For more information, call Annora Pharma Private Limited at 1-866-495-1995. Manufactured for: Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India.

Revised: 07/2022 promethazine-camber-logo

📋 Description 113 words ▾

DESCRIPTION Each rectal suppository contains 12.5 mg or 25 mg promethazine hydrochloride. The inactive ingredients present are ascorbyl palmitate, colloidal silicon dioxide, glyceryl monostearate, hard fat, and white wax. Promethazine hydrochloride suppositories, USP are for rectal administration only.

Promethazine hydrochloride is a racemic compound; the empirical formula is C 17 H 20 N 2 S•HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride with the following structural formula: Promethazine hydrochloride USP occurs as a white to faint yellowish, crystalline powder. It is very soluble in water, freely soluble in ethanol and in methanol, practically insoluble in ethyl acetate, diethyl ether and acetone. promethazine-structure

💬 Information for Patients 98 words ▾

Information for Patients Promethazine hydrochloride suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS−CNS Depression and PRECAUTIONS−Drug Interactions ).

Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine hydrochloride suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Information for Patients Promethazine hydrochloride suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.

The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS−CNS Depression and PRECAUTIONS−Drug Interactions ). Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun. Drug Interactions CNS Depressants - Promethazine hydrochloride suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine hydrochloride. When given concomitantly with Promethazine hydrochloride suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.

Dosage must be individualized. Excessive amounts of promethazine hydrochloride relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine - Because of the potential for promethazine hydrochloride to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine hydrochloride suppositories overdose.

Anticholinergics - Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) - Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Promethazine hydrochloride suppositories.

Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Pregnancy Tests Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test An increase in blood glucose has been reported in patients receiving promethazine hydrochloride. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug.

Promethazine was nonmutagenic in the Salmonella test system of Ames. Pregnancy Teratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed.

Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on partu… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 63 words ▾

Nursing Mothers It is not known whether promethazine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 47 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Promethazine Hydrochloride Suppositories, USP 12.5 mg Carton Label Promethazine Hydrochloride Suppositories, USP 25 mg Carton Label promethazine-carton12-5mg promethacin-carton25mg

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
15.8K
Units reimbursed last 4 qtrs
258.7K
Gross reimbursed last 4 qtrs
$680.8K
Avg / prescription
$43.04
Avg / unit
$2.6313
Latest quarter Q1 2026
4.2KRx
Medicaid pays / ea
$2.6313
gross reimbursed
vs
NADAC / ea
$2.0348
acquisition cost
=
Spread
+$0.5965
+29% 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 ⓘ
25% FFS 75% MCO
Fee-for-service · 4,016 Rx Managed care · 11,801 Rx
State Medicaid map
Alaska: 726 units · 99.0 per 100k residents AK Maine: 494 units · 35.4 per 100k residents ME Washington: 5,198 units · 66.5 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: 466 units · 7.9 per 100k residents WI Michigan: 5,316 units · 53.0 per 100k residents MI New York: 5,179 units · 26.5 per 100k residents NY Vermont: 393 units · 60.7 per 100k residents VT New Hampshire: 632 units · 45.1 per 100k residents NH Oregon: 5,545 units · 131 per 100k residents OR Nevada: 5,763 units · 180 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,296 units · 40.4 per 100k residents IA Illinois: 1,042 units · 8.3 per 100k residents IL Indiana: 14,689 units · 214 per 100k residents IN Ohio: 25,746 units · 218 per 100k residents OH Pennsylvania: 7,991 units · 61.7 per 100k residents PA New Jersey: 985 units · 10.6 per 100k residents NJ Massachusetts: 2,279 units · 32.6 per 100k residents MA California: 35,354 units · 90.7 per 100k residents CA Utah: 1,217 units · 35.6 per 100k residents UT Colorado: 3,853 units · 65.5 per 100k residents CO Nebraska: 800 units · 40.4 per 100k residents NE Missouri: 4,027 units · 65.0 per 100k residents MO Kentucky: 8,042 units · 178 per 100k residents KY West Virginia: 1,370 units · 77.4 per 100k residents WV Virginia: 18,518 units · 212 per 100k residents VA Maryland: 5,945 units · 96.2 per 100k residents MD Connecticut: 3,097 units · 85.6 per 100k residents CT Rhode Island: 358 units · 32.7 per 100k residents RI Arizona: 7,984 units · 107 per 100k residents AZ New Mexico: 494 units · 23.4 per 100k residents NM Kansas: 599 units · 20.4 per 100k residents KS Arkansas: 442 units · 14.4 per 100k residents AR Tennessee: 3,584 units · 50.3 per 100k residents TN North Carolina: 17,067 units · 158 per 100k residents NC South Carolina: 7,777 units · 145 per 100k residents SC Delaware: no data reported DE Oklahoma: 1,389 units · 34.3 per 100k residents OK Louisiana: 7,783 units · 170 per 100k residents LA Mississippi: 1,848 units · 62.9 per 100k residents MS Alabama: 2,568 units · 50.3 per 100k residents AL Georgia: 10,400 units · 94.3 per 100k residents GA D.C.: 257 units · 37.8 per 100k residents DC Hawaii: 1,553 units · 108 per 100k residents HI Texas: 12,705 units · 41.7 per 100k residents TX Florida: 15,973 units · 70.6 per 100k residents FL
Units reimbursed · per 100k residents
7.9218
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 Ohio 218 /100k
2 Indiana 214 /100k
3 Virginia 212 /100k
4 Nevada 180 /100k
5 Kentucky 178 /100k
6 Louisiana 170 /100k
7 North Carolina 158 /100k
8 South Carolina 145 /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.
← 31722-0040-31 · Camber 31722-0042-47 · Camber →
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.