Home › NDC Lookup › Ingredients › Duloxetine › 87448-2201-06
Duloxetine 20 mg Capsule, Delayed Release, 1 capsule — NDC 87448-2201-06 package photo

Duloxetine 20 mg Capsule, Delayed Release, 1 capsule

by Northwestern Memorial HealthCare · 1 CAPSULE, DELAYED RELEASE in 1 POUCH (87448-2201-6)
NDC 87448-2201-06
🏷️ FDA NDC (as labeled) 87448-2201-6 billing pads the package segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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 →

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 (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 14, 2026 — CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. (Asclemed USA Inc.) · FDA recall D-0555-2026
Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0514-2026
Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0516-2026
Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0515-2026
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. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2027. 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) 87448-2201-6
Product NDC 87448-2201
11-digit billing NDC 87448220106
RxCUI 596926
UNII 9044SC542W
Application # ANDA208706
SPL Set ID 51e31953-49ad-1866-e063-6294a90a7fb0
Established class (EPC) Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of action Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Marketing start 2017-03-16
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance DULOXETINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 87448-2201-6 — a 5-4-1 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 package segment → 87448-2201-06. 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 Serotonin and Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Serotonin and Norepinephrine Reuptake Inhibitor
Drug family (ATC) Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors
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

LabelerNorthwestern Memorial HealthCare
Application holderAJANTA PHARMA LTD
FDA applicationANDA208706 (ANDA)
Labeler code87448
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio5 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

📗 Our plain-language guide HelloPharmacist
  • You're right to ask — duloxetine does a lot more than treat depression. It's also approved for generalized anxiety disorder, diabetic nerve pain, fibromyalgia, and chronic musculos...
  • What is duloxetine actually used for? My doctor prescribed it but I wasn't sure it was just for depression.
  • It depends on which product you have. Most duloxetine delayed-release capsules — including Cymbalta — must be swallowed whole. Crushing, chewing, or opening them damages the specia...
  • Can I open the capsule or crush it if I have trouble swallowing pills?
📖 Read our full Duloxetine guide →
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.

💊 What it looks like

Color blue / white
ShapeCapsule
ImprintDLX20;ap
Size14 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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 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 $0.3495 $0.35 / 1 capsule
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Duloxetine 20 mg 00228-2890-06 Actavis 60 capsules $0.117 AB Availability likely —
Duloxetine Delayed-Release 20 mg 51991-0746-05 Breckenridge 500 capsules $0.117 AB Availability likely —
Duloxetine 20 mg 68001-0594-06 BluePoint 60 capsules $0.117 AB Availability likely —
Duloxetine 20 mg 82009-0029-05 Quallent 500 capsules $0.117 AB Availability likely —
Duloxetine 20 mg 82009-0170-10 Quallent 1000 capsules $0.117 AB Availability likely —
Duloxetine Hydrochloride 20 mg 33342-0160-09 Macleods 60 capsules $0.119 AB FDA listed —
Duloxetine 20 mg 68180-0294-03 Lupin 1000 capsules $0.119 AB FDA listed —
Cymbalta 20 mg 00002-3235-60 Eli 60 capsules $7.984 — Availability likely —
Duloxetine 20 mg 00615-8494-39 NCS 30 capsules — AB FDA listed —
Duloxetine 20 mg 25000-0608-06 MARKSANS 60 capsules — — FDA listed —
Duloxetine 20 mg 27241-0097-05 Ajanta 500 capsules — AB FDA listed —
Duloxetine 20 mg 31722-0168-01 Camber 100 capsules — AB FDA listed —
Duloxetine 20 mg 43547-0379-03 Solco 30 capsules — AB FDA listed —
Duloxetine Hydrochloride 20 mg 46708-0278-10 Alembic 100 capsules — AB FDA listed —
Duloxetine 20 mg 47335-0381-08 Sun 100 capsules — — FDA listed —
duloxetine 20 mg 49252-0007-10 Inventia 30 capsules — AB FDA listed —
Duloxetine 20 mg 50090-6406-00 A-S 90 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 50090-6889-00 A-S 90 capsules — AB FDA listed —
Duloxetine 20 mg 50090-7812-00 A-S 90 capsules — AB FDA listed —
Duloxetine Hydrochloride 20 mg 50771-0201-01 Yaopharma 60 capsules — — FDA listed —
Duloxetine Delayed-Release 20 mg 51407-0817-60 Golden 60 capsules — AB FDA listed —
Duloxetine 20 mg 59651-0279-60 Aurobindo 60 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 60429-0164-60 Golden 60 capsules — AB Discontinued —
Duloxetine 20 mg 60760-0759-30 St. 30 capsules — AB FDA listed —
Duloxetine Hydrochloride 20 mg 62332-0278-30 Alembic 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 63187-0720-30 Proficient 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 63629-1990-01 Bryant 90 capsules — AB FDA listed —
Duloxetine 20 mg 65841-0799-06 Zydus 30 capsules — AB FDA listed —
Duloxetine 20 mg 67877-0263-01 Ascend 100 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 68071-2711-09 NuCare 90 capsules — AB FDA listed —
Duloxetine 20 mg 68071-3979-06 NuCare 60 capsules — AB FDA listed —
Duloxetine 20 mg 68788-4128-03 Preferred 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 68788-7897-03 Preferred 30 capsules — AB FDA listed —
duloxetine 20 mg 70247-0012-06 Qingdao 60 capsules — AB FDA listed —
Duloxetine 20 mg 70518-1139-00 REMEDYREPACK 30 capsules — AB FDA listed —
Duloxetine 20 mg 70518-4440-00 REMEDYREPACK 30 capsules — AB FDA listed —
Duloxetine 20 mg 71205-0005-30 Proficient 30 capsules — AB FDA listed —
Duloxetine 20 mg 71205-0525-30 Proficient 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 71335-0165-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 20 mg 71335-1964-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 20 mg 71335-2624-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 20 mg 71335-3062-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 20 mg 71610-0401-83 Aphena 3600 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 71610-0739-74 Aphena 500 capsules — AB FDA listed —
Duloxetine 20 mg 71610-0957-74 Aphena 500 capsules — AB FDA listed —
Duloxetine Delayed-Release 20 mg 72162-1597-05 Bryant 500 capsules — AB FDA listed —
Duloxetine D/R 20 mg 72189-0634-30 Direct_Rx 30 capsules — AB FDA listed —
Duloxetine 20 mg 76420-0633-01 Asclemed 100 capsules — AB FDA listed —
Duloxetine DR 20 mg 80425-0311-01 Advanced 30 capsules — AB FDA listed —
Duloxetine 20 mgthis 87448-2201-06 Northwestern 1 capsule — AB Discontinued —
Drizalma Sprinkle 20 mg 47335-0616-10 SUN 1000 capsules — — FDA listed —
Duloxetine 20 mg 85534-0050-00 HAWAII 30 capsules — AB FDA listed —
Duloxetine 20 mg 87063-0702-12 ASCLEMED 120 capsules — AB FDA listed —
Duloxetine 20 mg 85534-0016-00 HAWAII 30 capsules — AB FDA listed —
Duloxetine 20 mg 70954-0860-30 ANI 90 capsules — AB FDA listed —
Duloxetine 20 mg 51407-0807-10 Golden 1000 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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87448-2201-06 You're viewing this 1 CAPSULE, DELAYED RELEASE in 1 POUCH (87448-2201-6) 2017-03-16 Inactivated by FDA

🧭 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) ✓ Available
Package photos ✓ Available
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 ✓ 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.
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 87448-2201-6, 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: 87448-2201-06, written without dashes as 87448220106. 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 87448-2201-06, the first segment (87448) is the labeler code FDA assigned to Northwestern Memorial HealthCare; the middle segment (2201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Northwestern Memorial HealthCare 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.
📦 How Supplied / Storage and Handling 💬 Medication Guide
📦 How Supplied / Storage and Handling 41 words ▾

HOW SUPPLIED Duloxetine delayed-release capsules are available in: Strength: 20mg Body Color: White Cap Color: Blue Cap Imprint: ap Body Imprint: DLX20 Bottles of 90's pack NDC: 27241-097-90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Duloxetine Delayed-Release Capsules (doo lox’ e teen) Read this Medication Guide before you start taking duloxetine delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about: all risks and benefits of treatment with antidepressant medicines all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions? Duloxetine delayed-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.

Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness).

How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.

Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or feelings, especially if they are new, worse, or worry you. In an emergency, call 911. attempts to commit suicide acting on dangerous impulses acting aggressive, being angry, or violent thoughts about suicide or dying new or worse depression new or worse anxiety panic attacks feeling very agitated or restless new or worse irritability trouble sleeping an extreme increase in activity or talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses.

It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects.

Talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes.

Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider. What are duloxetine delayed-release capsules?

Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Duloxetine delayed-release capsules belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors). Duloxetine delayed-release capsules are also used to treat or manage: Generalized Anxiety Disorder (GAD) Diabetic Peripheral Neuropathic Pain (DPNP) Fibromyalgia (FM) Chronic Musculoskeletal Pain Who should not take duloxetine delayed-release capsules?

Do Not take duloxetine delayed-release capsules if you: take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not s…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87448-1701-02 · Northwestern 87449-0200-01 · Panama →
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.