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Carvedilol 25 mg Tablet, Film Coated, 100-count — NDC 65862-145-01 (Billing 65862-0145-01)

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

This is a package of 100 tablets of Carvedilol 25 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Sep 2007 and currently FDA-listed; retail pharmacies pay about $0.0324 per tablet (NADAC).

NDC 65862-0145-01
🏷️ FDA NDC (as labeled) 65862-145-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0324 NADAC Per package$3.24 / 100 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1565/unit · Part D plans $0.0650/unit — full pricing hub ↓
Product page 65862-0145-05 Also comes in: 500 tablets 65862-145-05 1000 tablets 65862-145-99 3000 tablets 65862-145-39
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 65862-145-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
65862 labeler · 145 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6586214501 7
Medicaid fills, this package
183 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Carvedilol (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 · Aug 20, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0594-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0578-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0577-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0579-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0588-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0587-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class III · Nov 15, 2021 · Terminated — Failed Impurities/Degradation Specifications (Aurobindo Pharma USA Inc.) · FDA recall D-0263-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65862-145-01
Product NDC 65862-145
11-digit billing NDC 65862014501
NCPDP billing unit EA — each (per item)
SPL Set ID 0301362f-c9b3-43fd-9c16-c515cd37c0db
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-05
Dosage form TABLET, FILM COATED
Substance CARVEDILOL

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

GPI-14 33300007000330
GPI class Carvedilol
GCN Seq No 019293
GCN 01551
HICL code 013795
Ingredient (HICL) Carvedilol
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7A
Therapeutic class — specific (HIC3) Alpha/Beta-Adrenergic Blocking Agents
AHFS code 12:16.04.12
AHFS class Selective Alpha-1-Adrenergic Block.agent
FDB label name CARVEDILOL 25 MG TABLET
FDB brand name Carvedilol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 019293
  • GCN: 01551
  • GPI-14 (Medi-Span): 33300007000330
  • HICL (First Databank): 013795
  • AHFS class code: 12:16.04.12
Why two NDCs? The FDA registers this code as 65862-145-01 — 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 → 65862-0145-01. 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 CARVEDILOL 25 MG TABLET Ingredient Carvedilol
📖 What it is MedlinePlus · NLM

Carvedilol is used to treat heart failure (condition in which the heart cannot pump enough blood to all parts of the body) and high blood pressure. It also is used to improve survival after a heart attack.  Carvedilol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Food slows how fast the medicine is absorbed. That lowers the chance of dizziness or lightheadedness when you stand up. It doesn't change how much of the drug your body takes in, s...
  • Why do I need to take Carvedilol with food?
  • No. Stopping suddenly can make chest pain worse and has led to heart attacks and dangerous heart rhythms, even in people who may not know they have heart disease. If you need to st...
  • It can, especially when you first start or when the dose goes up. Dizziness is the most common side effect. Until you know how it affects you, be careful with driving or hazardous...
📖 Read our full Carvedilol guide →
1
Nutrient depletion considerations

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

🧪 Full Carvedilol 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 eaPer package
Retail pharmacies payNADAC · weekly $0.032 $3.24 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1565 $15.65 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.0650 $6.50 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.036 $0.031
▼ Down 9% 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
65862-0145-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE $0.0324 / ea $3.24 2007-09-05 — Active
65862-0145-05 65862-145-05 Main listing 500 TABLET, FILM COATED in 1 BOTTLE $0.0324 / ea $16.18 2007-09-05 — Active
65862-0145-99 65862-145-99 1000 TABLET, FILM COATED in 1 BOTTLE — — 2007-09-05 — Active
65862-0145-39 65862-145-39 3000 TABLET, FILM COATED in 1 BAG — — — — Active

You're viewing the smallest of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0324 NADAC).

This pack accounts for about 2.3% of this product's recent Medicaid fills; most go to the 500 tablets pack. 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 65862-0145-05?
Both are Carvedilol 25 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 65862-0145-05 is the 500 tablets package.
What NDC number is used to bill for this package of Carvedilol 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
Carvedilol 25 mg 00781-5224-01 Sandoz 100 tablets $0.032 AB Discontinued save 1%
Carvedilol 25 mg 00093-7296-01 Teva 100 tablets $0.032 AB Availability likely —
Carvedilol 25 mg 00904-7308-61 Major 1 tablet $0.032 AB Availability likely —
Carvedilol 25 mgthis 65862-0145-01 Aurobindo 100 tablets $0.032 — Availability likely —
Carvedilol 25 mg 68001-0152-00 BluePoint 100 tablets $0.032 AB Availability likely —
Carvedilol 25 mg 68382-0095-01 Zydus 100 tablets $0.032 AB Availability likely —
Carvedilol 25 mg 68462-0165-01 Glenmark 100 tablets $0.032 AB Availability likely —
Carvedilol 25 mg 72888-0037-00 Advagen 1000 tablets $0.032 AB Availability likely —
Carvedilol 25 mg 82009-0128-05 Quallent 500 tablets $0.032 AB Availability likely —
Carvedilol 25 mg 00615-8390-30 NCS 5 tablets — AB Discontinued —
Carvedilol 25 mg 43063-0129-30 PD-Rx 30 tablets — AB FDA listed —
Carvedilol 25 mg 50090-1069-00 A-S 60 tablets — AB FDA listed —
Carvedilol 25 mg 50090-2119-00 A-S 60 tablets — AB FDA listed —
Carvedilol 25 mg 50090-4171-00 A-S 60 tablets — AB FDA listed —
Carvedilol 25 mg 50090-4898-00 A-S 90 tablets — AB FDA listed —
Carvedilol 25 mg 50090-5726-00 A-S 90 tablets — AB FDA listed —
Carvedilol 25 mg 50090-7849-00 A-S 60 tablets — AB FDA listed —
Carvedilol 25 mg 50090-7850-00 A-S 90 tablets — AB FDA listed —
Carvedilol 25 mg 51407-0042-01 Golden 100 tablets — AB FDA listed —
Carvedilol 25 mg 51655-0033-25 Northwind 60 tablets — AB FDA listed —
Carvedilol 25 mg 51655-0397-25 Northwind 60 tablets — AB FDA listed —
Carvedilol 25 mg 55111-0255-01 Dr. 100 tablets — AB FDA listed —
Carvedilol 25 mg 55154-2640-00 Cardinal 1 tablet — AB FDA listed —
Carvedilol 25 mg 58657-0753-01 Method 100 tablets — AB FDA listed —
Carvedilol 25 mg 63187-0131-30 Proficient 30 tablets — AB FDA listed —
Carvedilol 25 mg 63187-0409-30 Proficient 30 tablets — AB FDA listed —
Carvedilol 25 mg 65841-0619-01 Zydus 100 tablets — AB FDA listed —
Carvedilol 25 mg 67296-1899-06 RedPharm 60 tablets — AB FDA listed —
Carvedilol 25 mg 67296-1901-06 RedPharm 60 tablets — AB FDA listed —
Carvedilol 25 mg 68071-2773-06 NuCare 60 tablets — AB FDA listed —
Carvedilol 25 mg 68071-4956-06 NuCare 60 tablets — AB FDA listed —
Carvedilol 25 mg 68788-8231-01 Preferred 100 tablets — AB FDA listed —
Carvedilol 25 mg 68788-9265-01 Preferred 100 tablets — AB FDA listed —
Carvedilol 25 mg 70518-1826-00 REMEDYREPACK 30 tablets — AB FDA listed —
Carvedilol 25 mg 70518-2389-01 REMEDYREPACK 30 tablets — AB FDA listed —
Carvedilol 25 mg 71335-0273-01 Bryant 100 tablets — AB Discontinued —
Carvedilol 25 mg 71335-1463-01 Bryant 100 tablets — AB FDA listed —
Carvedilol 25 mg 71335-1623-01 Bryant 100 tablets — AB FDA listed —
Carvedilol 25 mg 71335-2023-01 Bryant 100 tablets — AB FDA listed —
Carvedilol 25 mg 71335-2474-01 Bryant 100 tablets — AB FDA listed —
Carvedilol 25 mg 71610-0067-60 Aphena 90 tablets — AB FDA listed —
Carvedilol 25 mg 72189-0663-90 Direct_Rx 90 tablets — AB FDA listed —
Carvedilol 25 mg 72789-0440-90 PD-Rx 90 tablets — AB FDA listed —
Carvedilol 25 mg 72888-0502-01 Advagen 100 tablets — AB FDA listed —
Carvedilol 25 mg 76385-0113-01 UNICHEM 100 tablets — AB FDA listed —
Coreg 25 mg 80725-0142-20 Waylis 100 tablets — AB FDA listed —
Carvedilol 25 mg 82804-0138-60 Proficient 60 tablets — AB FDA listed —
Carvedilol 25 mg 82804-0183-90 Proficient 90 tablets — AB FDA listed —
Carvedilol 25 mg 63629-4070-01 Bryant 100 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

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 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 Carvedilol 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 marketedSep 2007
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
183
Units reimbursed last 4 qtrs
12.2K
Gross reimbursed last 4 qtrs
$1.9K
Avg / prescription
$10.44
Avg / unit
$0.1565
Latest quarter Q1 2026
47Rx
Medicaid pays / ea
$0.1565
gross reimbursed
vs
NADAC / ea
$0.0324
acquisition cost
=
Spread
+$0.1241
+383% 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 ⓘ
62% FFS 38% MCO
Fee-for-service · 113 Rx Managed care · 70 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 8,808 units · 45.0 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: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 445 units · 4.0 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,362 units · 4.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.045.0
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 New York 45.0 /100k
2 Texas 4.5 /100k
3 Georgia 4.0 /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.
500 tablets65862-0145-05 7,685 Rx · $76,018
100 tablets this page65862-0145-01 183 Rx · $1,910
1000 tablets65862-0145-99 No Medicaid data
3000 tablets65862-0145-39 No Medicaid data
Drug total (last 4 qtrs): 7,868 Rx · 595,400 units · $77,928 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 Carvedilol (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 Carvedilol. CMS lists 2 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
$36.64M
Claims incl. refills
3.9M
Beneficiaries
2.8M
Spend / beneficiary
$12.90
Spend / claim
$9.29
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 500 tablets (65862-0145-05), 1000 tablets (65862-0145-99), 3000 tablets (65862-0145-39). 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.
← 65862-0144-01 · Aurobindo 65862-0146-36 · 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.