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💊no package photo
in the FDA label

TAMSULOSIN HYDROCHLORIDE 0.4 mg Capsule, 500-count

by Wockhardt USA LLC. · 500 CAPSULE in 1 BOTTLE (64679-516-03)
NDC 64679-0516-03
🏷️ FDA NDC (as labeled) 64679-516-03 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0537 NADAC Per package$26.85 / 500 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2110/unit — full pricing hub ↓
Also comes in: 100 capsules 64679-0516-02
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 64679-516-03
Product NDC 64679-516
11-digit billing NDC 64679051603
NCPDP billing unit EA — each (per item)
Application # ANDA078938
Established class (EPC) Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2023)
Route ORAL
Dosage form CAPSULE
Substance TAMSULOSIN HYDROCHLORIDE
GCN Seq No 027546
GCN 48191
HICL code 013864
Ingredient (HICL) Tamsulosin Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q9
Therapeutic class — intermediate (HIC2) Urological Preparations
HIC3 code Q9B
Therapeutic class — specific (HIC3) Benign Prostatic Hypertrophy/Micturition Agents
AHFS code 12:16.04.12
AHFS class Selective Alpha-1-Adrenergic Block.agent
FDB label name TAMSULOSIN HCL 0.4 MG CAPSULE
FDB brand name Tamsulosin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 64679-516-03 — 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 → 64679-0516-03. 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

LabelerWockhardt USA LLC.
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA078938 (ANDA)
Labeler code64679
Product typeHuman Prescription Drug
Portfolio3 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

Label name TAMSULOSIN HCL 0.4 MG CAPSULE Ingredient Tamsulosin Hcl
📖 What it is MedlinePlus · NLM

Tamsulosin is used to treat benign prostatic hyperplasia (BPH; enlarged prostate that can cause difficulty urinating, painful urination or increased urinary frequency or urgency). Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Your prostate contains tiny muscle fibers that can squeeze too tight when the prostate is enlarged, making it hard to urinate. Tamsulosin blocks the signals that keep those muscles...
  • What exactly does tamsulosin do for my prostate?
  • Yes — timing really does matter with this one. Take your capsule about 30 minutes after the same meal every day. Taking it on an empty stomach pushes blood levels much higher, whic...
  • Does it matter when I take it or whether I eat first?
📖 Read our full Tamsulosin 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.

🧪 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 eaPer package
Retail pharmacies payNADAC · weekly $0.054 $26.85 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.2110 $105.50 / 500 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jun 2022 Aug 2022 Nov 2022 Feb 2024 $0.059 $0.054
▼ Down 2% over the last 9 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tamsulosin Hydrochloride .4 mg 00904-7383-61 Major 100 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 50268-0740-15 AvPAK 50 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 57237-0014-01 Rising 100 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 62135-0775-30 Chartwell 30 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 65862-0598-01 Aurobindo 100 capsules $0.051 — Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 67877-0450-01 Ascend 100 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 68084-0299-01 American 100 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 68382-0132-01 Zydus 100 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 72603-0115-01 NorthStar 100 capsules $0.051 AB Availability likely save 5%
Tamsulosin hydrochloride .4 mg 76282-0744-05 EXELAN 500 capsules $0.051 AB Availability likely save 5%
Tamsulosin Hydrochloride .4 mg 82009-0025-10 Quallent 1000 capsules $0.051 AB Availability likely save 5%
tamsulosin hydrochloride .4 mg 00781-2076-01 Sandoz 100 capsules $0.054 — FDA listed —
Tamsulosin Hydrochloride 0.4 mgthis 64679-0516-03 Wockhardt 500 capsules $0.054 AB Discontinued —
Tamsulosin Hydrochloride .4 mg 00115-8211-01 Amneal 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 00615-8055-05 NCS 15 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 33342-0159-07 Macleods 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 42291-0989-10 AvKARE 1000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 43063-0725-30 PD-Rx 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 43063-0947-30 PD-Rx 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-1846-00 A-S 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-3646-00 A-S 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-4906-00 A-S 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-5553-00 A-S 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-6699-00 A-S 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-6700-00 A-S 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 51407-0879-90 Golden 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 51655-0832-52 Northwind 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 55154-2142-00 Cardinal 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 55154-2636-00 Cardinal 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 60760-0598-90 St. 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 61919-0703-90 DIRECT 5904900000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 62756-0160-08 Sun 100 capsules — — FDA listed —
Tamsulosin Hydrochloride .4 mg 63187-0358-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 63187-0371-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 63187-0469-30 Proficient 30 capsules — — FDA listed —
Tamsulosin Hydrochloride .4 mg 63629-4346-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin hydrochloride .4 mg 63672-0021-09 Synthon 20000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 65841-0695-01 Zydus 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 67046-1015-03 Coupler 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 67296-2220-01 Redpharm 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-1840-01 NuCare 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-2561-01 NuCare 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-4443-01 NuCare 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-4872-09 NuCare 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-5118-01 NuCare 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68788-7050-01 Preferred 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 70518-0179-00 REMEDYREPACK 30 capsules — AB Discontinued —
Tamsulosin Hydrochloride .4 mg 70518-2052-00 REMEDYREPACK 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71205-0217-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71205-0688-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71335-0398-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71335-1538-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71335-1784-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71610-0724-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71610-0738-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71610-0835-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin hydrochloride .4 mg 71610-0910-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72162-2217-05 Bryant 500 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72162-2502-00 Bryant 1000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72162-2509-01 Bryant 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72865-0282-01 XLCare 100 capsules — AB FDA listed —
tamsulosin hydrochloride .4 mg 72865-0350-05 XLCare 500 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ 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 64679-0516-03, 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 – Q2 2025 · 2 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
28
Units reimbursed last 4 qtrs
1.9K
Gross reimbursed last 4 qtrs
$398.78
Avg / prescription
$14.24
Avg / unit
$0.2110
Latest quarter Q2 2025
11Rx
Medicaid pays / ea
$0.2110
gross reimbursed
vs
NADAC / ea
$0.0537
acquisition cost
=
Spread
+$0.1573
+293% 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 ⓘ
100% FFS
Fee-for-service · 28 Rx Managed care · 0 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: 1,890 units · 9.7 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: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
9.79.7
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 9.7 /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 capsules64679-0516-02 38 Rx · $473
500 capsules this page64679-0516-03 28 Rx · $399
Drug total (last 4 qtrs): 66 Rx · 3,457 units · $872 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tamsulosin Hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue1,552
Dyspnoea1,477
Dizziness1,307
Diarrhoea1,268
Headache991
Fall938
Asthenia923

Reporter sex

21,328 reports
Male · 95%
Female · 5%
Unknown · 0%

Serious outcomes

Death2,262
Disabling709
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,272 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 Per unit Per pack Marketing startStatus
64679-0516-02 100 CAPSULE in 1 BOTTLE (64679-516-02) $0.0537 / ea $5.37 2010-04-27 Discontinued by firm
64679-0516-03 You're viewing this 500 CAPSULE in 1 BOTTLE (64679-516-03) $0.0537 / ea $26.87 2010-04-27 Discontinued by firm

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0537 NADAC).

Pack size FAQ

What quantity is in NDC 64679-0516-03?
NDC 64679-0516-03 is a 500-count package — 500 capsule in 1 bottle.
What is the difference between NDC 64679-0516-03 and NDC 64679-0516-02?
Both are TAMSULOSIN HYDROCHLORIDE 0.4 mg Capsule — the drug itself is identical. NDC 64679-0516-03 is the 500-count package, while NDC 64679-0516-02 is the 100 capsules package.
What NDC number is used to bill for this package of TAMSULOSIN HYDROCHLORIDE 0.4 mg Capsule?
Bill NDC 64679-0516-03 — the 11-digit billing format is 64679051603. 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.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
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 ✓ Available
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

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 64679-516-03, 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: 64679-0516-03, written without dashes as 64679051603. 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 64679-0516-03, the first segment (64679) is the labeler code FDA assigned to Wockhardt USA LLC.; the middle segment (0516) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 capsules (64679-0516-02). 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?
Wockhardt USA LLC. 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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 prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, 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.
← 64678-0211-01 · Emergent 64679-0698-01 · Wockhardt →
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.