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Promethazine Hydrochloride 25 mg Tablet, 10-count — NDC 51655-0758-53 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 Tablet, 10-count — NDC 51655-758-53 (Billing 51655-0758-53)

by Northwind Health Company, LLC · 10 TABLET in 1 BOTTLE, PLASTIC

This is a package of 10 tablets of Promethazine Hydrochloride 25 mg Tablet from Northwind Health Company, LLC, marketed since Oct 2023 and currently FDA-listed.

NDC 51655-0758-53
🏷️ FDA NDC (as labeled) 51655-758-53 billing pads the product segment with a zero
This package
Contains10-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1075/unit — full pricing hub ↓
Product page 51655-0758-20 Also comes in: 15 tablets 51655-758-54 20 tablets 51655-758-20 30 tablets 51655-758-52
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51655-758-53
Product NDC 51655-758
11-digit billing NDC 51655075853
RxCUI 992447
UNII R61ZEH7I1I
Application # ANDA091179
SPL Set ID 075f052e-7f38-7f75-e063-6394a90a512b
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 2023-10-04
Route ORAL
Dosage form TABLET
Substance PROMETHAZINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 992447
Why two NDCs? The FDA registers this code as 51655-758-53 — 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 → 51655-0758-53. 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

📗 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 eachPer 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 · Q2 2026 $0.1075 $1.08 / 10 tablets
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
51655-0758-20 51655-758-20 Main listing 20 TABLET in 1 BOTTLE, PLASTIC 2023-10-04 — Active
51655-0758-52 51655-758-52 30 TABLET in 1 BOTTLE, PLASTIC 2024-04-30 — Active
51655-0758-53 You're viewing this 10 TABLET in 1 BOTTLE, PLASTIC 2023-10-12 — Active
51655-0758-54 51655-758-54 15 TABLET in 1 BOTTLE, PLASTIC 2024-01-03 — Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 10-count package — 10 tablet in 1 bottle, plastic.
How does this package differ from NDC 51655-0758-54?
Both are Promethazine Hydrochloride 25 mg Tablet — the drug itself is identical. This page's package is the 10-count one, while NDC 51655-0758-54 is the 15 tablets package.
What NDC number is used to bill for this package of Promethazine Hydrochloride 25 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Promethazine Hydrochloride 25 mg 00591-5307-01 Actavis 100 tablets $0.045 — Availability likely —
Promethazine Hydrochloride 25 mg 00904-7304-61 Major 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 10702-0003-01 KVK-Tech, 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 53746-0521-01 Amneal 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 65162-0521-10 Amneal 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 68001-0162-00 BluePoint 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 68084-0155-01 American 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 68382-0041-01 Zydus 100 tablets $0.045 AB Availability likely —
Promethazine Hydrochloride 25 mg 00615-8154-39 NCS 30 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 43063-0405-01 PD-Rx 1 tablet — AB FDA listed —
Promethazine Hydrochloride 25 mg 43063-0874-01 PD-Rx 100 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4452-00 A-S 5 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4453-00 A-S 12 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4608-00 A-S 90 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4750-00 A-S 12 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4811-00 A-S 5 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4812-00 A-S 90 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4813-00 A-S 12 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 50090-4875-00 A-S 12 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 51655-0085-20 Northwind 20 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 51655-0140-52 Northwind 30 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 51655-0462-27 Northwind 12 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mgthis 51655-0758-53 Northwind 10 tablets — AB FDA listed —
Promethazine 25 mg 54348-0117-00 PharmPak, 1 tablet — AB FDA listed —
Promethazine Hydrochloride 25 mg 55154-3373-00 Cardinal 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 63187-0829-10 Proficient 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 65841-0041-01 Zydus 100 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68071-4424-01 NuCare 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68071-4544-02 NuCare 12 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68071-4686-01 NuCare 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68071-4737-03 NuCare 30 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68071-4809-02 NuCare 20 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68071-4865-04 NuCare 4 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 68788-7886-01 Preferred 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 70518-1306-01 REMEDYREPACK 6 tablets — AB Discontinued —
Promethazine Hydrochloride 25 mg 70518-4419-00 REMEDYREPACK 30 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 71205-0126-10 Proficient 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 71205-0658-10 Proficient 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 71205-0805-15 Proficient 15 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 71335-1139-00 Bryant 14 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 71335-1359-00 Bryant 14 tablets — AB Discontinued —
Promethazine Hydrochloride 25 mg 72189-0176-10 DIRECT 10 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 76420-0679-01 Asclemed 100 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 80425-0265-01 Advanced 20 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 85766-0109-00 Sportpharm 1000 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 87063-0015-00 ASCLEMED 1000 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 67046-1043-03 Coupler 30 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 87441-0070-01 Unit 30 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 82868-0115-20 Northwind 20 tablets — AB FDA listed —
Promethazine Hydrochloride 25 mg 67296-0198-04 Redpharm 10 tablets — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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
ShapeRound
ImprintAN;521
Size7 mm
ScoringScored — splits in 2
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.

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

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

3 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

LabelerNorthwind Health Company, LLC
Application holderAMNEAL PHARMACEUTICALS NY LLC
FDA applicationANDA091179 (ANDA)
Labeler code51655
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio578 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 129 words ▾

INDICATIONS AND USAGE Promethazine hydrochloride tablets 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 and 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 postoperative 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 tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients ). 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 mg 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 eight to twelve 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 tablets, syrup, or rectal suppositories, 12.5 mg 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. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository.

12.5mg to 25 mg doses may be repeated, as necessary, at four- to six-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 post-operative period, the average dose is 25 mg repeated at four- to six-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 mg to 25 mg promethazine hydrochloride by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 mg to 50 mg for nighttime, pre-surgical, or obstetrical sedation.

Pre- and Post-operative Use Promethazine hydrochloride in 12.5 mg to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For pre-operative 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.

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

⛔ Contraindications 58 words ▾

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

⚠️ Warnings ~2 min read ▾

WARNINGS PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POST-MARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE 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 tablets 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 tablets may lead to potentially fatal respiratory depression.

Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold Promethazine hydrochloride tablets 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 tablets, should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis has 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 consideration 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.

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 reoccurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered.

Use in Pediatric Patients PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. CAUTION SHOULD BE… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 169 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.

🆘 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 115 words ▾

HOW SUPPLIED Promethazine Hydrochloride Tablets USP, 25 mg are white to off-white, flat-faced, beveled edge, round, uncoated tablets, debossed with “AN” above “521” with single line bisect separating them on one side and plain on the other side are supplied as: Bottles of 10: NDC 51655-758-53 Bottles of 15: NDC 51655-758-54 Bottles of 20: NDC 51655-758-20 Bottles of 30: NDC 51655-758-52 Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

09-2021-00

📋 Description 122 words ▾

DESCRIPTION Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10- [2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural formula: Promethazine hydrochloride is a racemic compound; the molecular formula is C 17 H 20 N 2 S HCl and its molecular weight is 320.88 g/mol. Promethazine hydrochloride, USP occurs as a white to faint yellowish crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether.

Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake.

1

⚠️ 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 tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Information for Patients Promethazine hydrochloride tablets 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 tablets 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 tablets, 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 tablets 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 tablets.

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 non-mutagenic 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 mg/kg 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 devel… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 6 words ▾

Principal Display Panel NDC: 51655-758-54 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — 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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Northwind Health Company, 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 3 other package presentations of this same product, including 15 tablets (51655-0758-54), 20 tablets (51655-0758-20), 30 tablets (51655-0758-52). 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?
Northwind Health Company, 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.
← 51655-0757-26 · Northwind 51655-0759-52 · Northwind →
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.