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Duloxetine Hydrochloride 60 mg Capsule, Delayed Release Pellets, 55,000-count — NDC 73476-748-00 (Billing 73476-0748-00)

by Towa Pharmaceutical Europe, S.L. · 55000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM

This is a package of 55,000 capsules of Duloxetine Hydrochloride 60 mg Capsule, Delayed Release Pellets from Towa Pharmaceutical Europe, S.L., marketed since Jan 2016 and currently FDA-listed. It is this product's only package size.

NDC 73476-0748-00
🏷️ FDA NDC (as labeled) 73476-748-00 billing pads the product segment with a zero
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

⚠️
Other active recalls for Duloxetine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 4, 2026 — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit (Breckenridge Pharmaceutical, Inc.) · FDA recall D-0583-2026
Class II · Jun 4, 2026 — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit (Breckenridge Pharmaceutical, Inc.) · FDA recall D-0582-2026
Class II · Apr 21, 2026 — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit (Breckenridge Pharmaceutical, Inc.) · FDA recall D-0522-2026
Class II · Nov 24, 2025 — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit (Breckenridge Pharmaceutical, Inc.) · FDA recall D-0216-2026
Class II · Nov 24, 2025 — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit (Breckenridge Pharmaceutical, Inc.) · FDA recall D-0215-2026
Class II · Oct 9, 2025 — CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. (Breckenridge Pharmaceutical, Inc.) · FDA recall D-0100-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73476-748-00
Product NDC 73476-748
11-digit billing NDC 73476074800
SPL Set ID 6f3542ae-692d-4f39-bad7-e72c6078d55a
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-26
Dosage form CAPSULE, DELAYED RELEASE PELLETS
Substance DULOXETINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 73476-748-00 — 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 → 73476-0748-00. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats major depressive disorder and generalized anxiety disorder. It is also used for diabetic nerve pain, fibromyalgia, and chronic musculoskeletal pain such as low back or os...
  • Take it by mouth, usually once a day, with or without food. Swallow the capsule whole and don’t crush, chew, or open it, unless you have Drizalma Sprinkle, which can be opened over...
  • Nausea, dry mouth, sleepiness, constipation, less appetite, and sweating are the most common. Headache and dizziness also occur. Call your doctor for yellow skin or eyes, a blister...
  • Please don’t stop suddenly. Stopping abruptly can cause discontinuation symptoms, so your prescriber will lower the dose gradually. Check in with them before making any change.
📖 Read our full Duloxetine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Duloxetine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Duloxetine nutrient depletion report →
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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
73476-0748-00 You're viewing this Main listing 55000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Duloxetine Hydrochloride 60 mg 33342-0162-07 Macleods 30 capsules $0.115 AB FDA listed —
Duloxetine Delayed-Release 60 mg 51991-0748-10 Breckenridge 1000 capsules $0.135 AB Availability likely —
Duloxetine 60 mg 82009-0032-10 Quallent 1000 capsules $0.135 AB Availability likely —
Cymbalta 60 mg 00002-3270-30 Eli 30 capsules $8.972 — Discontinued —
Duloxetine 60 mg 63187-0666-30 Proficient 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 63187-0735-30 Proficient 30 capsules — AB FDA listed —
Duloxetine 60 mg 25000-0610-03 MARKSANS 30 capsules — — FDA listed —
Duloxetine Delayed-Release 60 mg 51407-0819-10 Golden 1000 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 70518-0122-05 REMEDYREPACK 90 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 72162-1599-01 Bryant 100 capsules — AB FDA listed —
Duloxetine Hydrochloride 60 mg 59651-0282-30 Aurobindo 30 capsules — — FDA listed —
Duloxetine Hydrochloride 60 mgthis 73476-0748-00 Towa 55000 capsules — — FDA listed —
Duloxetine Delayed-Release 60 mg 63629-1992-01 Bryant 90 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 71335-0509-01 Bryant 30 capsules — AB Discontinued —
Duloxetine hydrochloride 60 mg 00110-3270-05 Lilly 150000 capsules — — FDA listed —
Duloxetine Hydrochloride 60 mg 50771-0203-01 Yaopharma 30 capsules — — FDA listed —
Duloxetine Delayed-Release 60 mg 71610-0743-30 Aphena 30 capsules — AB FDA listed —
Duloxetine hydrochloride 60 mg 00110-9542-15 Lilly 155000 capsules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerTowa Pharmaceutical Europe, S.L.
Labeler code73476
First marketedJan 2016
Product typeDrug For Further Processing
Portfolio6 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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Towa Pharmaceutical Europe, S.L. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — 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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Towa Pharmaceutical Europe, S.L.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Towa Pharmaceutical Europe, S.L. 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.
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.
← 73476-0747-00 · Towa 73476-0750-00 · Towa →
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.