Promethazine Hydrochloride 25 mg Tablet, 100-count
by Zydus Lifesciences Limited · 100 TABLET in 1 BOTTLE (65841-041-01)
NDC 65841-0041-01
🏷️ FDA NDC (as labeled)
65841-041-01
billing pads the product segment with a zero
This package
Contains100-count
Pack sizes3 compare ↓
Also priced by: Part D plans $0.1075/unit — full pricing hub ↓
Rx only
Generic
On market
Non-controlled
🗂️ 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 →
🆔 Identity & classification
FDA NDC (as labeled)
65841-041-01
Product NDC
65841-041
11-digit billing NDC
65841004101
UNII
R61ZEH7I1I
Application #
ANDA040596
SPL Set ID
4eaa8291-9cde-4205-857b-925ea8d618ba
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
2005-12-14
Route
ORAL
Dosage form
TABLET
Substance
PROMETHAZINE HYDROCHLORIDE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 65841-041-01 — 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 → 65841-0041-01. 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.
🏭 Manufacturer & labeler
LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA040596 (ANDA)
Labeler code65841
First marketedDec 2005
Product typeHuman Prescription Drug
Portfolio717 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.
🩺 Clinical
📖 What it is MedlinePlus · NLM
Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. P...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Promethazine has several uses. It's most commonly used for allergy symptoms like hay fever, hives, and itchy or watery eyes. It's also used to prevent or treat nausea and vomiting...
- Yes — drowsiness is the most common and expected side effect. You should avoid driving, operating machinery, or doing anything that requires sharp focus until you know how it affec...
- Will promethazine make me really drowsy?
- Promethazine is strictly off-limits for children under 2 years old — it can slow or stop breathing, and there have been fatalities reported in this age group. For children 2 and ol...
Patient education
Supplement & herbal interactions
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.
💬 Questions about Promethazine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeRound
ImprintZC03
Size1 mm
ScoringNot scored
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 2165RE0K14
A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
-
UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
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.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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 system | Per each | Per 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 | $10.75 / 100 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 51655-0758-20 | Northwind | 20 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 mgthis 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
🏛️
2005
On the market since
Dec 2005
📍
2026
Currently FDA-listed
21 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Promethazine Hydrochloride — the ingredient across all brands.
Top reported reactions
Reporter sex
Male · 28%
Female · 72%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65841-0041-01 You're viewing this | 100 TABLET in 1 BOTTLE (65841-041-01) | 2005-12-14 | Active |
| 65841-0041-05 | 500 TABLET in 1 BOTTLE (65841-041-05) | 2005-12-14 | Active |
| 65841-0041-10 | 1000 TABLET in 1 BOTTLE (65841-041-10) | 2005-12-14 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 65841-0041-01?
NDC 65841-0041-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 65841-0041-01 and NDC 65841-0041-05?
Both are Promethazine Hydrochloride 25 mg Tablet — the drug itself is identical. NDC 65841-0041-01 is the 100-count package, while NDC 65841-0041-05 is the 500 tablets package.
What NDC number is used to bill for this package of Promethazine Hydrochloride 25 mg Tablet?
Bill NDC 65841-0041-01 — the 11-digit billing format is 65841004101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 65841-041-01, 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: 65841-0041-01, written without dashes as 65841004101. 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 65841-0041-01, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0041) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Zydus Lifesciences Limited. 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 2 other package presentations of this same product, including 500 tablets (65841-0041-05), 1000 tablets (65841-0041-10). 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?
Zydus Lifesciences Limited 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.
📄 FDA label ▾
No readable label sections were found for this product.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.