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Quetiapine Fumarate 25 mg Tablet, Film Coated, 100-count — NDC 65862-489-01 (Billing 65862-0489-01)

by Aurobindo Pharma Limited · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Quetiapine Fumarate 25 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Mar 2012 and currently FDA-listed; retail pharmacies pay about $0.0215 per tablet (NADAC). It is the main listing for this product, which comes in 4 package sizes.

NDC 65862-0489-01
🏷️ FDA NDC (as labeled) 65862-489-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0215 NADAC Per package$2.15 / 100 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1616/unit · Part D plans $0.1085/unit — full pricing hub ↓
Main listing for product 65862-489 · Also comes in: 10 tablets 65862-489-10 1000 tablets 65862-489-99 5000 tablets 65862-489-59
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 8, 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 65862-489-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
65862 labeler · 489 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6586248901 2
Medicaid fills, this package
68,041 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65862-489-01
Product NDC 65862-489
11-digit billing NDC 65862048901
NCPDP billing unit EA — each (per item)
SPL Set ID ee4f6b18-7e0b-4631-8e47-9d33cd28a979
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-03-27
Dosage form TABLET, FILM COATED
Substance QUETIAPINE FUMARATE

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

GPI-14 59153070100310
GPI class QUEtiapine Fumarate
GCN Seq No 034187
GCN 67661
HICL code 014015
Ingredient (HICL) Quetiapine Fumarate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7T
Therapeutic class — specific (HIC3) Antipsychotic,Atypical,Dopamine,Serotonin Antagnst
AHFS code 28:16.08.04
AHFS class Atypical Antipsychotics
FDB label name QUETIAPINE FUMARATE 25 MG TAB
FDB brand name Quetiapine Fumarate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 034187
  • GCN: 67661
  • GPI-14 (Medi-Span): 59153070100310
  • HICL (First Databank): 014015
  • AHFS class code: 28:16.08.04
Why two NDCs? The FDA registers this code as 65862-489-01 — 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 → 65862-0489-01. 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.

Clinical

Label name QUETIAPINE FUMARATE 25 MG TAB Ingredient Quetiapine Fumarate
📖 What it is MedlinePlus · NLM

Quetiapine is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves), bipolar disorder (a disease that causes depression, mania, and other abnormal moods) and major depressive disorder. Quetiapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats schizophrenia and bipolar disorder, including manic and depressive episodes. Extended-release versions can also be added to an antidepressant for major depressive disorde...
  • Regular tablets can be taken with or without food. Extended-release tablets are taken once daily, usually in the evening, without food or with a light meal, and must be swallowed w...
  • Sleepiness, dry mouth, dizziness, constipation, increased appetite and weight gain are the most common. Many people notice these early on. Tell your doctor if they bother you.
  • Call right away for suicidal thoughts, worsening mood, fever with stiff muscles and confusion, uncontrolled movements, fainting, seizures, signs of infection, or high blood sugar s...
📖 Read our full Quetiapine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.022 $2.15 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1616 $16.16 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1085 $10.85 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.036 $0.022
▼ Down 34% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
65862-0489-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE $0.0215 / ea $2.15 2012-03-27 — Active
65862-0489-10 65862-489-10 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK — — 2012-03-27 — Active
65862-0489-99 65862-489-99 1000 TABLET, FILM COATED in 1 BOTTLE — — 2012-03-27 — Active
65862-0489-59 65862-489-59 5000 TABLET, FILM COATED in 1 BAG — — — — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 65862-0489-99?
Both are Quetiapine Fumarate 25 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 65862-0489-99 is the 1000 tablets package.
What NDC number is used to bill for this package of Quetiapine Fumarate 25 mg Tablet, Film Coated?
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
Quetiapine 25 mg 00093-2063-01 Teva 100 tablets $0.021 AB Availability likely —
Quetiapine 25 mg 00904-6638-61 Major 100 tablets $0.021 AB Availability likely —
Quetiapine Fumarate 25 mg 16571-0717-01 Rising 100 tablets $0.021 AB Availability likely —
Quetiapine Fumarate 25 mg 16714-0375-01 NorthStar 100 tablets $0.021 AB Availability likely —
Quetiapine Fumarate 25 mg 29300-0147-01 Unichem 100 tablets $0.021 AB Availability likely —
Quetiapine Fumarate 25 mg 31722-0764-01 Camber 100 tablets $0.021 AB Availability likely —
Quetiapine 25 mg 43547-0518-10 Solco 100 tablets $0.021 AB Availability likely —
Quetiapine Fumarate 25 mg 50268-0630-15 AvPAK 50 tablets $0.021 AB Availability likely —
Quetiapine fumarate 25 mg 60687-0327-01 American 100 tablets $0.021 AB Availability likely —
Quetiapine Fumarate 25 mgthis 65862-0489-01 Aurobindo 100 tablets $0.021 — Availability likely —
Quetiapine 25 mg 67877-0242-01 Ascend 100 tablets $0.021 AB Availability likely —
Quetiapine fumarate 25 mg 68001-0185-00 BluePoint 100 tablets $0.021 AB Availability likely —
Quetiapine fumarate 25 mg 68180-0445-01 Lupin 100 tablets $0.021 AB Availability likely —
Quetiapine fumarate 25 mg 82009-0095-01 Quallent 100 tablets $0.021 AB Availability likely —
Quetiapine fumarate 25 mg 47335-0902-18 Sun 1000 tablets $0.023 — Discontinued +7%
Quetiapine 25 mg 16729-0145-01 Accord 100 tablets $0.028 — Availability likely +29%
Quetiapine fumarate 25 mg 33342-0099-11 Macleods 100 tablets $0.036 AB FDA listed +67%
Seroquel 25 mg 00310-0275-10 AstraZeneca 100 tablets $3.711 AB Availability likely +17183%
Quetiapine Fumarate 25 mg 00054-0220-20 Hikma 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 00615-8470-05 NCS 15 tablets — AB FDA listed —
Quetiapine 25 mg 42291-0695-10 AvKARE 1000 tablets — AB Discontinued —
Quetiapine Fumarate 25 mg 46708-0134-10 Alembic 100 tablets — — FDA listed —
Quetiapine Fumarate 25 mg 50090-3333-00 A-S 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 51407-0066-01 Golden 100 tablets — AB FDA listed —
Quetiapine 25 mg 55154-7881-00 Cardinal 10 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 60760-0764-30 ST. 30 tablets — AB FDA listed —
Seroquel 25 mg 61269-0250-10 H2-Pharma, 100 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 63187-0452-03 Proficient 3 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 67046-1440-03 Coupler 30 tablets — — FDA listed —
Quetiapine fumarate 25 mg 68071-3676-09 NuCare 90 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 68071-3931-09 NuCare 90 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 68788-8764-01 : 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 68788-8823-01 Preferred 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 70518-3747-00 REMEDYREPACK 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 71205-0826-30 Proficient 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 71335-1562-01 Bryant 30 tablets — AB Discontinued —
Quetiapine Fumarate 25 mg 71335-2679-01 Bryant 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 71610-0140-30 Aphena 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 72189-0446-30 Direct_Rx 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 72865-0264-01 XLCare 100 tablets — AB FDA listed —
Quetiapine 25 mg 76420-0512-01 ASCLEMED 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 87002-0000-00 Klocke 48780 tablets — — FDA listed —
Quetiapine fumarate 25 mg 16364-0145-22 Intas 5000 tablets — — FDA listed —
Quetiapine fumarate 25 mg 59765-0145-22 Intas 5000 tablets — — FDA listed —
Quetiapine fumarate 25 mg 87441-0074-01 Unit 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 70518-4705-00 REMEDYREPACK 30 tablets — 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

🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 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.

🧪 Avoiding an ingredient? See Quetiapine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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 code65862
First marketedMar 2012
Product typeDrug For Further Processing
Portfolio1,464 products on file

More NDCs from Aurobindo Pharma Limited labeler code 65862

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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
68K
Units reimbursed last 4 qtrs
3.5M
Gross reimbursed last 4 qtrs
$566.4K
Avg / prescription
$8.32
Avg / unit
$0.1616
Latest quarter Q1 2026
15.3KRx
Medicaid pays / ea
$0.1616
gross reimbursed
vs
NADAC / ea
$0.0215
acquisition cost
=
Spread
+$0.1401
+652% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
36% FFS 64% MCO
Fee-for-service · 24,578 Rx Managed care · 43,463 Rx
State Medicaid map
Alaska: no data reported AK Maine: 496 units · 35.6 per 100k residents ME Washington: no data reported WA Idaho: 6,075 units · 309 per 100k residents ID Montana: no data reported MT North Dakota: 4,537 units · 579 per 100k residents ND Minnesota: 91,668 units · 1,598 per 100k residents MN Wisconsin: 111,463 units · 1,886 per 100k residents WI Michigan: 155,892 units · 1,553 per 100k residents MI New York: 540,388 units · 2,761 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 29,048 units · 906 per 100k residents IA Illinois: 237,475 units · 1,892 per 100k residents IL Indiana: 294,933 units · 4,298 per 100k residents IN Ohio: 533,742 units · 4,529 per 100k residents OH Pennsylvania: 582,435 units · 4,494 per 100k residents PA New Jersey: 360,097 units · 3,876 per 100k residents NJ Massachusetts: 18,726 units · 267 per 100k residents MA California: 5,239 units · 13.4 per 100k residents CA Utah: 1,290 units · 37.8 per 100k residents UT Colorado: 39,867 units · 678 per 100k residents CO Nebraska: 16,508 units · 835 per 100k residents NE Missouri: 84,331 units · 1,361 per 100k residents MO Kentucky: 30,340 units · 670 per 100k residents KY West Virginia: 16,385 units · 926 per 100k residents WV Virginia: 70,706 units · 811 per 100k residents VA Maryland: 175,940 units · 2,847 per 100k residents MD Connecticut: 8,480 units · 234 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 14,334 units · 488 per 100k residents KS Arkansas: 1,770 units · 57.7 per 100k residents AR Tennessee: 1,707 units · 24.0 per 100k residents TN North Carolina: 13,623 units · 126 per 100k residents NC South Carolina: no data reported SC Delaware: 25,493 units · 2,473 per 100k residents DE Oklahoma: 13,803 units · 341 per 100k residents OK Louisiana: 2,480 units · 54.2 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 5,338 units · 786 per 100k residents DC Hawaii: no data reported HI Texas: 9,365 units · 30.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
13.44,529
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 4,529 /100k
2 Pennsylvania 4,494 /100k
3 Indiana 4,298 /100k
4 New Jersey 3,876 /100k
5 Maryland 2,847 /100k
6 New York 2,761 /100k
7 Delaware 2,473 /100k
8 Illinois 1,892 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 tablets this page65862-0489-01 68,041 Rx · $566,353
10 tablets65862-0489-10 No Medicaid data
1000 tablets65862-0489-99 No Medicaid data
5000 tablets65862-0489-59 No Medicaid data
Drug total (last 4 qtrs): 68,041 Rx · 3,503,974 units · $566,353 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Quetiapine Fumarate (matched by generic name) — the program that covers self-administered drugs. 15 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Quetiapine Fumarate. CMS lists 4 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$46.34M
Claims incl. refills
2.4M
Beneficiaries
1M
Spend / beneficiary
$45.82
Spend / claim
$19.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 — 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 — 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) ✓ Available
“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.
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 3 other package presentations of this same product, including 10 tablets (65862-0489-10), 1000 tablets (65862-0489-99), 5000 tablets (65862-0489-59). 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.
← 65862-0488-37 · Aurobindo 65862-0490-01 · Aurobindo →
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.