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Acetaminophen 650 mg Tablet, Extended Release, 35,000-count

by Aurobindo Pharma Limited · 35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39)
NDC 59651-0034-39
🏷️ FDA NDC (as labeled) 59651-034-39 billing pads the product segment with a zero
This package
Contains35,000-count Pack sizes2 compare ↓
Also comes in: 1500 tablets 59651-0034-15
On market Non-controlled
🗂️ 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 Acetaminophen (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 · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 59651-034-39
Product NDC 59651-034
11-digit billing NDC 59651003439
SPL Set ID 48138e38-40a9-4122-aa05-ae3e5fbf412a
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-09
Dosage form TABLET, EXTENDED RELEASE
Substance ACETAMINOPHEN
Why two NDCs? The FDA registers this code as 59651-034-39 — 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 → 59651-0034-39. 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.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code59651
First marketedNov 2016
Product typeDrug For Further Processing
Portfolio1,449 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
  • Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
  • What is acetaminophen actually used for?
  • That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
  • How much is too much? I'm worried about taking it too often.
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

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

🧪 Full Acetaminophen 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 · 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: 1500 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
major acetaminophen 650 mg 00904-6883-65 Major 400 tablets $0.063 — Availability likely —
8 Hour Arthritis Pain 650 mg 46122-0629-71 AMERISOURCE 50 tablets $0.063 — Availability likely —
8 Hour Pain Relief 650 mg 70677-1123-01 STRATEGIC 100 tablets $0.063 — Availability likely —
8HR Arthritis Pain Relief 650 mg 70000-0733-01 LEADER/ 100 tablets $0.063 — Availability likely —
8 Hour Pain Relief 650 mg 46122-0630-78 AMERISOURCE 100 tablets $0.063 — Availability likely —
Acetaminophen 650 mg 70010-0160-01 Granules 100 tablets $0.063 — Availability likely —
8HR Muscle Aches and Pain Relief 650 mg 70000-0734-01 LEADER/ 100 tablets $0.063 — Availability likely —
8 Hour Pain Relief 650 mg 83324-0082-50 CHAIN 50 tablets $0.063 — Availability likely —
8hr arthritis pain relief 650 mg 00904-7561-60 Major 100 tablets $0.063 — Availability likely —
good sense pain relief arthritis pain 650 mg 00113-0544-62 L. 24 tablets $0.069 — Discontinued —
Acetaminophen 650 mg 00363-0340-08 Walgreen 80 tablets — — FDA listed —
Arthritis Pain Relief 650 mg 36800-0632-01 TOPCO 24 tablets — — FDA listed —
topcare 8 hr arthritis pain relief 650 mg 36800-0779-47 Topco 150 tablets — — FDA listed —
Pain Relief 8 HR 650 mg 37808-0747-71 H 50 tablets — — FDA listed —
Pain Relief 650 mg 41250-0802-62 Meijer 24 tablets — — FDA listed —
arthritis pain relief 650 mg 41250-0966-47 Meijer 150 tablets — — FDA listed —
Equate 8HR Arthritis Pain Relief 650 mg 49035-0741-62 Wal-Mart 24 tablets — — FDA listed —
8HR Arthritis Pain 650 mg 72036-0200-04 HARRIS 100 tablets — — FDA listed —
basic care acetaminophen 650 mg 72288-0634-78 Amazon.com 100 tablets — — FDA listed —
Arthritis Pain 650 mg 21130-0097-01 BETTER 100 tablets — — FDA listed —
Acetaminophen Extended-Release Tablets, 650 mg 25000-0071-02 MARKSANS 24 tablets — — FDA listed —
Acetaminophen Extended-Release Tablets, 650 mg 25000-0108-02 MARKSANS 24 tablets — — FDA listed —
Heb 650 mg 37808-0120-02 HEB 50 tablets — — FDA listed —
eight hour pain relief 650 mg 41163-0203-02 United 50 tablets — — FDA listed —
8 hr Arthritis Pain Relief 650 mg 55910-0892-05 DOLGENCORP, 50 tablets — — FDA listed —
8 hr Pain Relief 650 mg 55910-0895-05 DOLGENCORP, 50 tablets — — FDA listed —
Arthritis Pain Relief 650 mg 67091-0401-02 WINCO 50 tablets — — FDA listed —
8 Hour Arthritis Pain 650 mg 68998-0401-03 MARC 100 tablets — — FDA listed —
equate 8hr arthritis pain relief 650 mg 79903-0345-33 WALMART 325 tablets — — FDA listed —
8 Hour Arthritis Pain 650 mg 83324-0083-01 CHAIN 100 tablets — — FDA listed —
Pain Relief 650 mg 42507-0303-03 HYVEE 100 tablets — — FDA listed —
Tylenol 8 Hr Arthritis Pain 650 mg 50580-0575-01 Kenvue 24 tablets — — FDA listed —
Tylenol 8 Hr Muscle Aches And Pain 650 mg 50580-0576-01 Kenvue 24 tablets — — FDA listed —
Acetaminophen 650 mg 57896-0268-01 GERI-CARE 100 tablets — — FDA listed —
Acetaminophen 650 mg 62207-0188-49 Granules 1000 tablets — — FDA listed —
arthritis pain reliever 650 mg 00363-0544-62 Walgreen 24 tablets — — Discontinued —
Arthritis Pain Reliever 650 mg 00363-9781-01 WALGREENS 100 tablets — — FDA listed —
acetaminophen 650 mg 62207-0234-35 Granules 18000 tablets — — FDA listed —
Good Sense Pain Relief 650 mg 00113-0044-71 L. 50 tablets — — Discontinued —
Muscle Aches and Pains Acetaminophen extended release 650 mg 49483-0704-05 TIME 50 tablets — — FDA listed —
Acetaminophen 650 mg 62207-0183-34 Granules 5 tablets — — FDA listed —
Arthritis Pain 650 mg 68196-0034-02 SAM'S 200 tablets — — FDA listed —
Members Mark Arthritis Pain 650 mg 68196-0611-82 Sam's 200 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0297-10 CVS 100 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0635-07 CVS 24 tablets — — FDA listed —
Amazon Basic Care Acetaminophen 650 mg 72288-0698-10 Amazon.com 100 tablets — — FDA listed —
Acetaminophen 650 mg 11822-5019-02 RITE 100 tablets — — FDA listed —
Tylenol 8HR 650 mg 50580-0309-01 Kenvue 24 tablets — — FDA listed —
Midol Long Lasting Relief 650 mg 00280-8090-20 Bayer 20 tablets — — FDA listed —
Acetaminophen 650 mg 63868-0660-01 CHAIN 100 tablets — — FDA listed —
Acetaminophen 650 mg 72476-0186-05 RETAIL 50 tablets — — FDA listed —
8HR Arthritis Pain 650 mg 81522-0200-03 FSA 100 tablets — — FDA listed —
Arthritis Pain 650 mg 85828-0200-01 Grocery 24 tablets — — FDA listed —
Topcare 8 Hour Pain Relief 650 mg 36800-0369-78 Topco 100 tablets — — FDA listed —
Arthritis Pain 650 mg 42507-0205-01 HYVEE 24 tablets — — FDA listed —
Arthritis Pain 650 mg 53943-0200-02 DISCOUNT 50 tablets — — FDA listed —
dg health 8 hr arthritis pain relief 650 mg 55910-0828-62 Dolgencorp 24 tablets — — FDA listed —
Arthritis Pain 650 mg 57344-0200-02 AAA 50 tablets — — FDA listed —
Acetaminophen 650 mg 58602-0730-07 Aurohealth 24 tablets — — FDA listed —
Acetaminophen 650 mg 58602-0848-21 Aurohealth 100 tablets — — Discontinued —
8 Hour Pain Relief 650 mg 63941-0401-02 VALU 50 tablets — — FDA listed —
Acetaminophen 650 mg 00363-9993-15 WALGREENS 150 tablets — — FDA listed —
acetaminophen 650 mg 00113-4013-00 L. 98400 tablets — — FDA listed —
arthritis pain relief 650 mg 41250-0658-03 Meijer 100 tablets — — FDA listed —
CareOne 8 Hour Pain Relief 650 mg 41520-0127-71 American 50 tablets — — Discontinued —
Arthritis Pain Relief 650 mg 68016-0303-01 CHAIN 100 tablets — — FDA listed —
Acetaminophen 650 mg 00363-9604-07 WALGREEN 24 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0930-80 CVS 80 tablets — — FDA listed —
Acetaminophen 650 mg 79903-0132-25 WALMART 325 tablets — — FDA listed —
8HR Muscle Aches and Pain 650 mg 81522-0201-03 FSA 100 tablets — — FDA listed —
Acetaminophen 650 mg 00615-8624-39 NCS 30 tablets — — FDA listed —
Acetaminophen 650 mg 21130-0108-07 Better 24 tablets — — FDA listed —
8 Hr Muscle Aches And Pain 650 mg 51316-0354-42 CVS 24 tablets — — FDA listed —
8 hr arthritis pain 650 mg 51316-0504-79 CVS 400 tablets — — FDA listed —
Acetaminophen 650 mg 53329-0643-29 Medline 50 tablets — — FDA listed —
DG Health 8 Hour Pain Relief 650 mg 55910-0749-71 Dolgencorp 50 tablets — — FDA listed —
8 Hour Arthritis Pain 650 mg 63941-0300-02 VALU 50 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0322-10 CVS 100 tablets — — FDA listed —
good sense pain relief arthritis pain 650 mg 76420-0590-01 ASCLEMED 100 tablets — — FDA listed —
acetaminophen 650 mg 00113-4004-00 L. 99280 tablets — — FDA listed —
Acetaminophen 650 mgthis 59651-0034-39 Aurobindo 35000 tablets — — FDA listed —
8HR Pain Relief 650 mg 11673-0928-01 TARGET 100 tablets — — FDA listed —
Acetaminophen 650 mg 49035-0181-21 WAL-MART 225 tablets — — FDA listed —
Arthritis Pain 650 mg 61504-0200-03 AMERIFOODS 100 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0037-35 CVS 225 tablets — — FDA listed —
Acetaminophen 650 mg 00363-9992-10 WALGREENS 100 tablets — — FDA listed —
Leader 8HR Arthritis Pain Relief 650 mg 70000-0736-01 Cardinal 225 tablets — — FDA listed —
Acetaminophen 650 mg 72476-0185-05 RETAIL 50 tablets — — FDA listed —
Care One arthritis pain relief 650 mg 41520-0544-71 American 50 tablets — — FDA listed —
Acetaminophen 650 mg 11822-5091-04 RITE 100 tablets — — FDA listed —
Acetaminophen 650 mg 30142-0157-07 KROGER 24 tablets — — FDA listed —
Good Neighbor Pharmacy Menstrual Pain Relief 650 mg 46122-0836-70 Amerisource 20 tablets — — FDA listed —
Tylenol 8 HR Arthritis Pain 650 mg 50580-0783-10 Kenvue 100 tablets — — FDA listed —
Acetaminophen 650 mg 62207-0892-49 Granules 1000 tablets — — FDA listed —
8 Hour Pain Relief 650 mg 63868-0679-50 CHAIN 50 tablets — — FDA listed —
Acetaminophen 650 mg 71335-1340-01 Bryant 30 tablets — — FDA listed —
basic care acetaminophen 650 mg 72288-0544-79 Amazon.com 400 tablets — — FDA listed —
Equate Menstrual Pain Relief 650 mg 79903-0420-20 WALMART 20 tablets — — FDA listed —
acetaminophen 650 mg 10888-8175-01 Patheon 10000 tablets — — FDA listed —
topcare 8 hr arthritis pain relief 650 mg 36800-0455-62 Topco 24 tablets — — Discontinued —
Acetaminophen 650 mg 37835-0512-01 Bi-Mart 100 tablets — — FDA listed —
Arthritis Pain Relief 650 mg 41226-0699-01 KROGER 100 tablets — — FDA listed —
8 Hour Pain Relief 650 mg 41226-0704-01 KROGER 100 tablets — — FDA listed —
arthritis pain relief 650 mg 56062-0544-62 Publix 24 tablets — — FDA listed —
8HR Muscle Aches and Pain 650 mg 57344-0201-03 AAA 100 tablets — — FDA listed —
Acetaminophen 650 mg 58602-0873-07 Aurohealth 24 tablets — — FDA listed —
Acetaminophen 650 mg 69848-0015-10 Granules 100 tablets — — FDA listed —
good sense pain relief arthritis pain 650 mg 71335-2545-01 Bryant 30 tablets — — FDA listed —
8 HR Arthritis Pain 650 mg 75907-0430-01 Dr. 100 tablets — — 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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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.

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

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 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 Acetaminophen. 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
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
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.

🔬 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 Acetaminophen — the ingredient across all brands.

Top reported reactions

Pain49,512
Fatigue45,791
Nausea41,932
Overdose40,941
Drug Dependence39,209
Headache38,738
Death36,479

Age at onset

Neonate2,511
Infant1,510
Child4,320
Adolescent3,245
Adult56,522
Elderly41,990

Reporter sex

679,604 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization199,486
Death102,045
Life-threatening29,552
Disabling25,685
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 54,527 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59651-0034-15 1500 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-15) — Active
59651-0034-39 You're viewing this 35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 59651-0034-39?
NDC 59651-0034-39 is a 35,000-count package — 35000 tablet, extended release in 1 bag.
What is the difference between NDC 59651-0034-39 and NDC 59651-0034-15?
Both are Acetaminophen 650 mg Tablet, Extended Release — the drug itself is identical. NDC 59651-0034-39 is the 35,000-count package, while NDC 59651-0034-15 is the 1500 tablets package.
What NDC number is used to bill for this package of Acetaminophen 650 mg Tablet, Extended Release?
Bill NDC 59651-0034-39 — the 11-digit billing format is 59651003439. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — 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 FDA registers it as 59651-034-39, 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: 59651-0034-39, written without dashes as 59651003439. 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 59651-0034-39, the first segment (59651) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0034) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (39) identifies this exact package size and type. Together they name one specific package of one specific product.
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 1 other package presentation of this same product, including 1500 tablets (59651-0034-15). 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.

📄 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 ↗
← 59651-0033-99 · Aurobindo 59651-0035-71 · 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.