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Loxapine 5 mg Capsule, 80,300-count — NDC 0591-0369-00 (Billing 00591-0369-00)

by Actavis Pharma, Inc. · 80300 CAPSULE in 1 BAG

This is a package of 80,300 capsules of Loxapine 5 mg Capsule from Actavis Pharma, Inc., marketed since Jun 1988 and currently FDA-listed.

NDC 00591-0369-00
🏷️ FDA NDC (as labeled) 0591-0369-00 billing pads the labeler segment with a zero
This package
Contains80,300-count Pack sizes3 compare ↓
Product page 00591-0369-01 Also comes in: 100 capsules 0591-0369-01 5883 capsules 0591-0369-77
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 0591-0369-00 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
0591 labeler · 0369 product · 00 package
Package marketed since
Jun 15, 1988
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0591036900 2
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-0369-00
Product NDC 0591-0369
11-digit billing NDC 00591036900
SPL Set ID 4218946e-199a-4814-bc2c-ba9088967631
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1988-06-15
Dosage form CAPSULE
Substance LOXAPINE SUCCINATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 59154020200105
GPI class Loxapine Succinate
GCN Seq No 003983
GCN 15562
HICL code 001664
Ingredient (HICL) Loxapine Succinate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7U
Therapeutic class — specific (HIC3) Antipsychotics, Dopamine And Serotonin Antagonists
AHFS code 28:16.08.26
AHFS class Dibenzoxapines
FDB label name LOXAPINE 5 MG CAPSULE
FDB brand name Loxapine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003983
  • GCN: 15562
  • GPI-14 (Medi-Span): 59154020200105
  • HICL (First Databank): 001664
  • AHFS class code: 28:16.08.26
Why two NDCs? The FDA registers this code as 0591-0369-00 — a 4-4-2 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 labeler segment → 00591-0369-00. 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

Label name LOXAPINE 5 MG CAPSULE Ingredient Loxapine Succinate
📗 Our plain-language guide HelloPharmacist
  • Loxapine capsules treat schizophrenia. A separate inhaled product, Adasuve, calms sudden agitation linked to schizophrenia or bipolar I disorder in adults. A healthcare professiona...
  • They are taken by mouth, usually split into two to four doses a day. Your prescriber sets and adjusts the amount based on your symptoms. Take them exactly as directed and do not ch...
  • Sleepiness, dizziness and lightheadedness are common. Movement effects like tremor, stiffness or restlessness can happen. With Adasuve, an unusual taste and throat irritation are c...
  • Seek help for wheezing, shortness of breath or chest tightness after Adasuve. Also get help for high fever with severe stiffness and confusion, seizures, fainting, neck or throat m...
📖 Read our full Loxapine guide →
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.
Try another pack size: 100 capsules 5883 capsules
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 Per unit Per pack Marketing startMarketing endStatus
00591-0369-01 0591-0369-01 Main listing 100 CAPSULE in 1 BOTTLE, PLASTIC $0.3092 / ea $30.92 1988-06-15 — Active
00591-0369-00 You're viewing this 80300 CAPSULE in 1 BAG — — — — Active
00591-0369-77 0591-0369-77 5883 CAPSULE in 1 CONTAINER — — — — Active

You're viewing the largest of 3 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 80,300-count package — 80300 capsule in 1 bag.
How does this package differ from NDC 00591-0369-01?
Both are Loxapine 5 mg Capsule — the drug itself is identical. This page's package is the 80,300-count one, while NDC 00591-0369-01 is the 100 capsules package.
What NDC number is used to bill for this package of Loxapine 5 mg Capsule?
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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loxapine 5 mg 00527-1394-01 Lannett 100 capsules $0.309 AB Availability likely —
Loxapine 5 mg 62135-0492-60 Chartwell 60 capsules $0.309 AB Availability likely —
Loxapine 5 mg 64850-0890-01 Elite 100 capsules $0.309 AB Availability likely —
Loxapine 5 mgthis 00591-0369-00 Actavis 80300 capsules — — FDA listed —
Loxapine 5 mg 67046-1479-03 Coupler 30 capsules — AB FDA listed —
Loxapine 5 mg 70518-0346-00 REMEDYREPACK 30 capsules — AB FDA listed —
Loxapine 5 mg 82804-0051-30 Proficient 30 capsules — AB 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

🏛️
1988
On the market since
Jun 1988
📍
2026
Currently FDA-listed
38 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.

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.

Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedJun 1988
Product typeDrug For Further Processing
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

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 ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules00591-0369-01 2,319 Rx · $57,979
80300 capsules this page00591-0369-00 No Medicaid data
5883 capsules00591-0369-77 No Medicaid data
Drug total (last 4 qtrs): 2,319 Rx · 129,332 units · $57,979 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Loxapine — the ingredient across all brands.

Top reported reactions

Coma262
Somnolence255
Toxicity To Various Agents231
Drug Interaction217
Weight Increased209
Poisoning Deliberate206
Suicide Attempt177

Reporter sex

3,862 reports
Male · 56%
Female · 44%
Unknown · 0%

Serious outcomes

Death602
Life-threatening498
Disabling61
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 482 0
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.

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: Actavis Pharma, Inc. 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 Actavis Pharma, Inc.. 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 100 capsules (00591-0369-01), 5883 capsules (00591-0369-77). 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?
Actavis Pharma, 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.
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.
← 00591-0348-01 · Actavis 00591-0370-01 · Actavis →
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.