Home › NDC Lookup › Ingredients › Fluphenazine Hydrochloride › 59651-0689-05
Fluphenazine Hydrochloride 10 mg Tablet, 500-count — NDC 59651-0689-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fluphenazine Hydrochloride 10 mg Tablet, 500-count — NDC 59651-689-05 (Billing 59651-0689-05)

by Aurobindo Pharma Limited · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Fluphenazine Hydrochloride 10 mg Tablet from Aurobindo Pharma Limited, marketed since Aug 2023 and currently FDA-listed.

NDC 59651-0689-05
🏷️ FDA NDC (as labeled) 59651-689-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.5833/unit — full pricing hub ↓
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 →
⚠️
Other active recalls for Fluphenazine Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 25, 2026 — Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent. (Ajanta Pharma USA Inc) · FDA recall D-0836-2026
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0326-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0327-2025
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) 59651-689-05
Product NDC 59651-689
11-digit billing NDC 59651068905
NCPDP billing unit EA — each (per item)
SPL Set ID 3989e88e-b12f-46ca-8f32-0b095a98d068
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-18
Dosage form TABLET
Substance FLUPHENAZINE HYDROCHLORIDE

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

GPI-14 59200025100320
GCN Seq No 003824
GCN 14603
HICL code 001626
Ingredient (HICL) Fluphenazine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2G
Therapeutic class — specific (HIC3) Antipsychotics,Phenothiazines
AHFS code 28:16.08.24
AHFS class Phenothiazines
FDB label name FLUPHENAZINE 10 MG TABLET
FDB brand name Fluphenazine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003824
  • GCN: 14603
  • GPI-14 (Medi-Span): 59200025100320
  • HICL (First Databank): 001626
  • AHFS class code: 28:16.08.24
Why two NDCs? The FDA registers this code as 59651-689-05 — 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 → 59651-0689-05. 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 FLUPHENAZINE 10 MG TABLET Ingredient Fluphenazine Hcl
📗 Our plain-language guide HelloPharmacist
  • Fluphenazine is an antipsychotic medication used to manage psychotic disorders — most commonly schizophrenia. It's available as tablets, an oral liquid, and injections. The long-ac...
  • Fluphenazine Decanoate Injection is chemically designed to release slowly after a single shot, so one injection can keep working for up to four weeks or even longer. The regular ta...
  • How is the long-acting injection different from the tablets or regular shot?
  • The most common side effects involve movement — things like muscle stiffness, a restless, fidgety feeling, or tremors. These can often be managed by adjusting your dose or adding a...
📖 Read our full Fluphenazine 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 · Q2 2026 $0.5833 $291.65 / 500 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59651-0689-01 59651-689-01 Main listing 100 TABLET in 1 BOTTLE $0.4309 / ea $43.09 2023-08-18 — Active
59651-0689-05 You're viewing this 500 TABLET in 1 BOTTLE — — 2023-08-18 — Active
59651-0689-62 59651-689-62 30000 TABLET in 1 BAG — — — — Active

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

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

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 59651-0689-01?
Both are Fluphenazine Hydrochloride 10 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 59651-0689-01 is the 100 tablets package.
What NDC number is used to bill for this package of Fluphenazine Hydrochloride 10 mg Tablet?
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
Fluphenazine Hydrochloride 10 mg 00527-1791-01 Lannett 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 00832-6006-11 Upsher-Smith 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 00904-7160-61 Major 1 tablet $0.431 AB Availability likely —
Fluphenazine Hydrochoride 10 mg 16571-0892-09 Rising 90 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 24979-0139-01 Upsher-Smith 100 tablets $0.431 — Availability likely —
Fluphenazine hydrochloride 10 mg 27241-0252-01 Ajanta 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 31722-0387-01 Camber 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 43598-0037-01 Dr. 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 50268-0369-15 AvPAK 1 tablet $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 51672-4236-01 Sun 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 60687-0761-01 American 1 tablet $0.431 AB Availability likely —
fluphenazine hydrochloride 10 mg 62135-0419-90 Chartwell 90 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 62332-0791-31 Alembic 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 68462-0338-01 Glenmark 100 tablets $0.431 AB Availability likely —
fluphenazine hydrochloride 10 mg 69238-1681-01 Amneal 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 70710-1491-01 Zydus 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 70954-0276-10 ANI 100 tablets $0.431 AB Availability likely —
Fluphenazine Hydrochloride 10 mg 90096-0124-01 Zameer 100 tablets $0.498 AB FDA listed —
Fluphenazine Hydrochloride 10 mg 10135-0728-01 Marlex 100 tablets — AB FDA listed —
Fluphenazine Hydrochloride 10 mg 46708-0791-31 Alembic 100 tablets — AB FDA listed —
Fluphenazine Hydrochloride 10 mg 51407-0461-01 Golden 100 tablets — AB FDA listed —
Fluphenazine Hydrochloride 10 mgthis 59651-0689-05 Aurobindo 500 tablets — — FDA listed —
Fluphenazine Hydrochloride 10 mg 70518-4673-00 REMEDYREPACK 1 tablet — AB FDA listed —
Fluphenazine Hydrochloride 10 mg 70771-1584-01 Zydus 100 tablets — AB FDA listed —
Fluphenazine Hydrochloride 10 mg 71205-0840-00 Proficient 100 tablets — — FDA listed —
Fluphenazine Hydrochloride 10 mg 72205-0115-05 Novadoz 500 tablets — AB FDA listed —
Fluphenazine Hydrochoride 10 mg 70518-4691-00 REMEDYREPACK 1 tablet — 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color White / Yellow / Green / Orange
ShapeRound
ImprintFL;10
Size11 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.

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

LabelerAurobindo Pharma Limited
Labeler code59651
First marketedAug 2023
Product typeDrug For Further Processing
Portfolio1,456 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 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 tablets59651-0689-01 785 Rx · $29,094
30000 tablets59651-0689-62 No Medicaid data
Drug total (last 4 qtrs): 785 Rx · 35,675 units · $29,094 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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: Aurobindo Pharma Limited 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 ✓ 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 — 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 Aurobindo Pharma 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 100 tablets (59651-0689-01), 30000 tablets (59651-0689-62). 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?
Aurobindo Pharma 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.
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.
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.