Doxepin Hydrochloride 50 mg Capsule, 100-count
by JUBILANT CADISTA PHARMACEUTICALS INC. · 100 CAPSULE in 1 BOTTLE, PLASTIC (59746-702-01)
NDC 59746-0702-01
🏷️ FDA NDC (as labeled)
59746-702-01
billing pads the product segment with a zero
This package
Rx only
Generic
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Doxepin Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 25, 2025 — CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. (Alembic Pharmaceuticals Limited) · FDA recall D-0566-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
59746-702-01
Product NDC
59746-702
11-digit billing NDC
59746070201
NCPDP billing unit
EA — each (per item)
Application #
ANDA215483
Established class (EPC)
Tricyclic Antidepressant
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jul 2025)
Route
ORAL
Dosage form
CAPSULE
Substance
DOXEPIN HYDROCHLORIDE
GCN Seq No
046090
GCN
16567
HICL code
001650
Ingredient (HICL)
Doxepin Hcl
HIC1 code
H
Therapeutic class — broad (HIC1)
Nervous System (Except Autonomic)
HIC2 code
H2
Therapeutic class — intermediate (HIC2)
Psychoactive Drugs
HIC3 code
H2U
Therapeutic class — specific (HIC3)
Tricyclic Antidepressants,Rel.non-Sel.reupt-Inhib
AHFS code
28:16.04.28
AHFS class
Tricyclics, Other Norepi-Ru Inhibitors
FDB label name
DOXEPIN 50 MG CAPSULE
FDB brand name
Doxepin Hcl
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 59746-702-01 — 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 → 59746-0702-01. 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.
🏭 Manufacturer & labeler
LabelerJUBILANT CADISTA PHARMACEUTICALS INC.
Application holderJUBILANT CADISTA PHARMACEUTICALS INC
FDA applicationANDA215483 (ANDA)
Labeler code59746
Product typeHuman Prescription Drug
Portfolio46 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
Label name DOXEPIN 50 MG CAPSULE Ingredient Doxepin Hcl
📖 What it is MedlinePlus · NLM
Doxepin is used to treat depression and anxiety. Doxepin is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed for mental balance. Doxepin is also available as a tablet to treat insomnia. This monograph only gives information about doxepin for depression or anxiety. If you are using this medication for insomnia, read the monograph entitled doxepin (insomnia).
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Good question — doxepin does have a history as an antidepressant, but what you're being prescribed is a much lower-dose version specifically approved for sleep. It's used for peopl...
- What exactly is doxepin being used for here? I thought it was an antidepressant.
- Yes, timing really does matter. You should take doxepin at least 3 hours after your last meal — especially if that meal was high in fat. Eating close to your dose makes the medicat...
- Does it matter when I take it or if I eat first?
Patient education
Supplement & herbal interactions
1
Nutrient depletion considerations
Doxepin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 Doxepin Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.285 | $28.48 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 20% over the last 7 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxepin Hydrochloride 50 mg 00378-4250-01 | Mylan | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 00904-7054-61 | Major | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 23155-0796-01 | Heritage | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 24658-0795-01 | PURACAP | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin hydrochloride 50 mg 27241-0169-01 | Ajanta | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 51079-0438-20 | Mylan | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 59651-0175-01 | Aurobindo | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 62135-0562-90 | Chartwell | 90 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 62332-0645-31 | Alembic | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin hydrochloride 50 mg 64980-0596-01 | Rising | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 70756-0426-11 | Lifestar | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 72205-0090-91 | Novadoz | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 72603-0392-01 | NorthStar | 100 capsules | $0.153 | AB | Availability likely | save 46% |
| Doxepin Hydrochloride 50 mg 69315-0160-01 | Leading | 100 capsules | $0.285 | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71921-0164-01 | Florida | 100 capsules | $0.285 | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mgthis 59746-0702-01 | JUBILANT | 100 capsules | $0.285 | AB | Discontinued | — |
| Doxepin Hydrochloride 50 mg 69238-1171-01 | Amneal | 1000 capsules | $0.366 | AB | FDA listed | +28% |
| Doxepin Hydrochloride 50 mg 10267-5061-04 | Contract | 1000 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 42571-0422-01 | Micro | 100 capsules | — | AB | Discontinued | — |
| Doxepin Hydrochloride 50 mg 42806-0531-01 | Epic | 100 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 46708-0645-31 | Alembic | 100 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 48433-0037-20 | Safecor | 100 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 50090-5286-01 | A-S | 30 capsules | — | — | FDA listed | — |
| Doxepin Hydrochloride 50 mg 50090-7184-01 | A-S | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 50090-7819-01 | A-S | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 55801-0529-01 | Appco | 100 capsules | — | AB | FDA listed | — |
| Doxepin hydrochloride 50 mg 67046-0394-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Doxepin hydrochloride 50 mg 70518-3767-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 70518-4231-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 70518-4282-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71335-2408-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71335-2472-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71335-2804-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin hydrochloride 50 mg 71335-9732-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 81469-0417-01 | First | 100 capsules | — | 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
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 Doxepin hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 59746-0702-01 You're viewing this | 100 CAPSULE in 1 BOTTLE, PLASTIC (59746-702-01) | $0.2848 / ea | $28.48 | 2021-12-01 | Discontinued by firm |
| 59746-0702-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (59746-702-05) | — | — | 2021-12-01 | Discontinued by firm |
| 59746-0702-90 | 90 CAPSULE in 1 BOTTLE, PLASTIC (59746-702-90) | — | — | 2021-12-01 | Discontinued by firm |
You're viewing one of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 59746-0702-01?
NDC 59746-0702-01 is a 100-count package — 100 capsule in 1 bottle, plastic.
What is the difference between NDC 59746-0702-01 and NDC 59746-0702-90?
Both are Doxepin Hydrochloride 50 mg Capsule — the drug itself is identical. NDC 59746-0702-01 is the 100-count package, while NDC 59746-0702-90 is the 90 capsules package.
What NDC number is used to bill for this package of Doxepin Hydrochloride 50 mg Capsule?
Bill NDC 59746-0702-01 — the 11-digit billing format is 59746070201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| 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 full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 59746-702-01, 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: 59746-0702-01, written without dashes as 59746070201. 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 59746-0702-01, the first segment (59746) is the labeler code FDA assigned to JUBILANT CADISTA PHARMACEUTICALS INC.; the middle segment (0702) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 90 capsules (59746-0702-90), 500 capsules (59746-0702-05). 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?
JUBILANT CADISTA PHARMACEUTICALS INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 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 FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.
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.