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clindamycin hydrochloride 300 mg Capsule, 100-count

by Mylan Pharmaceuticals Inc. · 100 CAPSULE in 1 BOTTLE (59762-5010-2)
NDC 59762-5010-02
🏷️ FDA NDC (as labeled) 59762-5010-2 billing pads the package segment with a zero
This package
Contains100-count Cost per ea$0.1684 NADAC Per package$16.84 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.18/unit — full pricing hub ↓
Also comes in: 16 capsules 59762-5010-01
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 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 Clindamycin Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0344-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
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 Jun 2026. 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) 59762-5010-2
Product NDC 59762-5010
11-digit billing NDC 59762501002
NCPDP billing unit EA — each (per item)
RxCUI 197518, 284215
UNII T20OQ1YN1W
UPC 0359762501028, 0359762332813, 0359762501011
Application # NDA050162
SPL Set ID 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 1970-05-22
Marketing end 2026-06-30
Route ORAL
Dosage form CAPSULE
Substance CLINDAMYCIN HYDROCHLORIDE
GPI-14 16220020100120
GPI class Clindamycin HCl
GCN Seq No 009340
GCN 40832
HICL code 004044
Ingredient (HICL) Clindamycin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1K
Therapeutic class — specific (HIC3) Lincosamide Antibiotics
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLINDAMYCIN HCL 300 MG CAPSULE
FDB brand name Clindamycin 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 59762-5010-2 — a 5-4-1 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 package segment → 59762-5010-02. 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.

🏷️ RxNorm drug class

This medicine belongs to the Lincosamide Antibacterial class.

Pharmacologic class Lincosamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Antibiotics, Lincosamides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMylan Pharmaceuticals Inc.
Application holderPFIZER INC
FDA applicationNDA050162 (NDA AUTHORIZED GENERIC)
Labeler code59762
First marketedMay 1970
Product typeHuman Prescription Drug
Portfolio473 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 CLINDAMYCIN HCL 300 MG CAPSULE Ingredient Clindamycin Hcl
📖 What it is MedlinePlus · NLM

Clindamycin is used to treat certain types of bacterial infections. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Antibiotics such as clindamycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Clindamycin is used for serious bacterial infections — things like deep skin infections, lung abscesses, pelvic infections, and abdominal infections. It's often chosen when penicil...
  • What kinds of infections is clindamycin actually used for?
  • You don't have to eat with it — food doesn't meaningfully change how it's absorbed. But the most important thing is to take each capsule with a full, large glass of water, and stay...
  • Do I need to take clindamycin with food?
📖 Read our full Clindamycin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clindamycin 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 eaPer package
Retail pharmacies payNADAC · weekly $0.168 $16.84 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $1.18 $118.01 / 100 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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.274 $0.168
▼ Down 32% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin Hydrochloride 300 mg 00904-7194-61 Major 100 capsules $0.168 AB Availability likely —
Clindamycin Hydrochloride 300 mg 42571-0252-01 Micro 100 capsules $0.168 AB Availability likely —
Clindamycin Hydrochloride 300 mg 50268-0185-15 AvPAK 50 capsules $0.168 AB Availability likely —
clindamycin hydrochloride 300 mgthis 59762-5010-02 Mylan 100 capsules $0.168 AB Discontinued —
Clindamycin Hydrochloride 300 mg 62135-0766-01 Chartwell 100 capsules $0.168 AB Availability likely —
Clindamycin hydrochloride 300 mg 63304-0693-01 Sun 100 capsules $0.168 AB Availability likely —
Clindamycin Hydrochloride 300 mg 65862-0186-01 Aurobindo 100 capsules $0.168 AB Availability likely —
Clindamycin Hydrochloride 300 mg 68084-0244-01 American 100 capsules $0.168 AB Availability likely —
Clindamycin Hydrochloride 300 mg 68462-0144-01 GLENMARK 100 capsules $0.168 AB Availability likely —
Cleocin Hydrochloride 300 mg 00009-0395-14 Pharmacia 100 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 50090-0967-00 A-S 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 50090-3907-00 A-S 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 50090-4575-00 A-S 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 50090-7354-00 A-S 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 50090-7659-00 A-S 28 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 50090-7669-00 A-S 28 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 51655-0317-51 Northwind 40 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 55700-0761-21 Quality 21 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 60760-0827-10 St. 10 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 63187-0127-20 Proficient 20 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 63187-0141-20 Proficient 20 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 67046-2073-03 Coupler 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 67296-0940-02 Redpharm 28 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 67296-1749-03 RedPharm 40 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 67296-2149-01 Redpharm 21 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 68071-2346-09 NuCare 9 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 68071-3577-01 NuCare 14 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 68071-3983-09 NuCare 9 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 68071-4257-01 NuCare 14 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 68071-5174-02 NuCare 20 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 68788-8685-01 Preferred 14 capsules — AB FDA listed —
clindamycin hydrochloride 300 mg 69238-2121-03 Amneal 10 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 70518-2153-00 REMEDYREPACK 30 capsules — AB Discontinued —
Clindamycin Hydrochloride 300 mg 70518-3772-00 REMEDYREPACK 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 71205-0444-20 Proficient 20 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 71335-0320-00 Bryant 16 capsules — AB Discontinued —
Clindamycin Hydrochloride 300 mg 71335-1412-00 Bryant 16 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 71335-2432-00 Bryant 16 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 71335-2677-01 Bryant 10 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 72189-0189-30 DIRECT 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 72789-0167-09 PD-Rx 9 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 72789-0207-09 PD-Rx 9 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 76420-0202-12 Asclemed 12 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 76420-0614-01 Asclemed 100 capsules — AB FDA listed —
Clindamycin HCL 300 mg 80425-0103-01 Advanced 30 capsules — AB FDA listed —
Clindamycin HCL 300 mg 80425-0145-01 Advanced 30 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 80425-0416-01 Advanced 21 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 82804-0278-21 Proficient 21 capsules — AB FDA listed —
Clindamycin Hydrochloride 300 mg 83939-0019-01 VERITYRX, 1 capsule — AB FDA listed —
Clindamycin Hydrochloride 300 mg 85766-0028-01 Sportpharm 100 capsules — AB FDA listed —
Clindamycin hydrochloride 300 mg 85534-0088-00 HAWAII 8 capsules — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
1970
On the market since
May 1970
📍
2026
Currently FDA-listed
56 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.

🗺️ 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 59762-5010-02, 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 – Q4 2025 · 4 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
3.6K
Units reimbursed last 4 qtrs
90.7K
Gross reimbursed last 4 qtrs
$107.1K
Avg / prescription
$30.16
Avg / unit
$1.1801
Latest quarter Q4 2025
829Rx
Medicaid pays / ea
$1.1801
gross reimbursed
vs
NADAC / ea
$0.1684
acquisition cost
=
Spread
+$1.0117
+601% 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 ⓘ
43% FFS 57% MCO
Fee-for-service · 1,529 Rx Managed care · 2,022 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 5,580 units · 71.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 911 units · 15.9 per 100k residents MN Wisconsin: 929 units · 15.7 per 100k residents WI Michigan: 788 units · 7.9 per 100k residents MI New York: 15,944 units · 81.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,812 units · 42.8 per 100k residents OR Nevada: 1,182 units · 37.0 per 100k residents NV Wyoming: no data reported WY South Dakota: 2,095 units · 228 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 932 units · 7.9 per 100k residents OH Pennsylvania: 2,715 units · 20.9 per 100k residents PA New Jersey: 1,470 units · 15.8 per 100k residents NJ Massachusetts: no data reported MA California: 8,733 units · 22.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 750 units · 12.1 per 100k residents MO Kentucky: 5,809 units · 128 per 100k residents KY West Virginia: 2,748 units · 155 per 100k residents WV Virginia: 3,030 units · 34.8 per 100k residents VA Maryland: 2,331 units · 37.7 per 100k residents 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: 1,094 units · 15.4 per 100k residents TN North Carolina: 7,771 units · 71.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,502 units · 32.8 per 100k residents LA Mississippi: 454 units · 15.4 per 100k residents MS Alabama: 3,232 units · 63.3 per 100k residents AL Georgia: 5,879 units · 53.3 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 3,408 units · 11.2 per 100k residents TX Florida: 306 units · 1.4 per 100k residents FL
Units reimbursed · per 100k residents
1.4228
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 South Dakota 228 /100k
2 West Virginia 155 /100k
3 Kentucky 128 /100k
4 New York 81.5 /100k
5 North Carolina 71.7 /100k
6 Washington 71.4 /100k
7 Alabama 63.3 /100k
8 Georgia 53.3 /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 capsules this page59762-5010-02 3,551 Rx · $107,087
16 capsules59762-5010-01 558 Rx · $7,691
Drug total (last 4 qtrs): 4,109 Rx · 104,314 units · $114,778 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 Clindamycin Hydrochloride — the ingredient across all brands.

Top reported reactions

Diarrhoea285
Rash271
Nausea254
Pain230
Dyspnoea212
Drug Hypersensitivity193
Headache177

Age at onset

Neonate1
Infant1
Child9
Adolescent15
Adult468
Elderly272

Reporter sex

3,587 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization1,358
Death241
Life-threatening199
Disabling85
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 456 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
59762-5010-01 16 CAPSULE in 1 BOTTLE (59762-5010-1) $0.1759 / ea $2.81 1970-05-22 Discontinued by firm
59762-5010-02 You're viewing this 100 CAPSULE in 1 BOTTLE (59762-5010-2) $0.1684 / ea $16.84 1970-05-22 Discontinued by firm

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1684 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 86% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 59762-5010-02?
NDC 59762-5010-02 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 59762-5010-02 and NDC 59762-5010-01?
Both are clindamycin hydrochloride 300 mg Capsule — the drug itself is identical. NDC 59762-5010-02 is the 100-count package, while NDC 59762-5010-01 is the 16 capsules package. Per-ea NADAC also differs: $0.1684 here vs $0.1759 for the 16 capsules pack.
What NDC number is used to bill for this package of clindamycin hydrochloride 300 mg Capsule?
Bill NDC 59762-5010-02 — the 11-digit billing format is 59762501002. 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) ✓ 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 ✓ 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

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 59762-5010-2, 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: 59762-5010-02, written without dashes as 59762501002. 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 59762-5010-02, the first segment (59762) is the labeler code FDA assigned to Mylan Pharmaceuticals Inc.; the middle segment (5010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 16 capsules (59762-5010-01). 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?
Mylan Pharmaceuticals Inc. 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 219 words ▾

WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin HCl and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile . Because clindamycin HCl therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section.

It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C . difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.

Because of the risk of colitis, as described in the BOXED WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.

Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections.

Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin HCl and other antibacterial drugs, Clindamycin HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, this antibacterial drug should be discontinued (see BOXED WARNING ). Administer clindamycin hydrochloride capsules with a full glass of water (6 to 8 ounces, approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce the potential for esophageal irritation (see ADVERSE REACTIONS ). Adults: Serious infections - 150 to 300 mg every 6 hours.

More severe infections - 300 to 450 mg every 6 hours. Pediatric Patients (who are able to swallow capsules) : Serious infections - 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections - 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.

Clindamycin should be dosed based on total body weight regardless of obesity. Clindamycin hydrochloride capsules are not suitable for pediatric patients who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the clindamycin palmitate oral solution in some cases.

Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE ® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules, USP. In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Clindamycin hydrochloride is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

⚠️ Warnings ~2 min read ▾

WARNINGS See BOXED WARNING Clostridioides difficile- Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin HCl, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile . C. difficile produces toxins A and B, which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS ).

Severe hypersensitivity reactions, including acute myocardial ischemia with or without myocardial infarction, and severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported (see ADVERSE REACTIONS ). In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

Nephrotoxicity Clindamycin is potentially nephrotoxic and cases with acute kidney injury have been reported. Consider monitoring of renal function particularly in patients with pre-existing renal dysfunction or those taking concomitant nephrotoxic drugs. In case of acute kidney injury, discontinue clindamycin HCl when no other etiology is identified.

Usage in Meningitis Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (see BOXED WARNING ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ).

Esophagitis and esophageal ulcer have been reported, particularly when taken in a lying position or with a small amount of water. An unpleasant or metallic taste has been reported after oral administration. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions.

Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as toxic epidermal necrolysis, some with fatal outcome, have been reported (see WARNINGS ). Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction, acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction, cutaneous vasculitis, symmetrical drug-related intertriginous and flexural exanthema, and hypersensitivity have also been reported.

Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions ). Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Renal: Acute kidney injury (see WARNINGS ).

Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune System : Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Musculoskeletal: Cases of polyarthritis have been reported.

🔄 Drug Interactions 125 words ▾

Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.

Therefore, inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

🤰 Pregnancy 146 words ▾

Pregnancy Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.

Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m 2 , respectively) revealed no evidence of teratogenicity.

🧒 Pediatric Use 23 words ▾

Pediatric Use When clindamycin hydrochloride is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.

🧓 Geriatric Use 103 words ▾

Geriatric Use Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibacterial drug-associated colitis and diarrhea (due to Clostridioides difficile ) seen in association with most antibacterial drugs occur more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.

Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.

🆘 Overdosage 48 words ▾

OVERDOSAGE Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Human Pharmacology Absorption Pharmacokinetic studies with a 150 mg oral dose of clindamycin hydrochloride in 24 normal adult volunteers showed that clindamycin was rapidly absorbed after oral administration. An average peak serum concentration of 2.50 mcg/mL was reached in 45 minutes; serum concentrations averaged 1.51 mcg/mL at 3 hours and 0.70 mcg/mL at 6 hours. Absorption of an oral dose is virtually complete (90%), and the concomitant administration of food does not appreciably modify the serum concentrations; serum concentrations have been uniform and predictable from person to person and dose to dose.

Pharmacokinetic studies following multiple doses of clindamycin hydrochloride for up to 14 days show no evidence of accumulation or altered metabolism of drug. Doses of up to 2 grams of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses. Distribution Concentrations of clindamycin in the serum increased linearly with increased dose.

Serum concentrations exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Clindamycin is widely distributed in body fluids and tissues (including bones). No significant concentrations of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

Metabolism In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin. Excretion The average biological half-life is 2.4 hours. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites.

Specific Populations Patients with Renal/Hepatic Impairment The elimination half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Dosage schedules do not need to be modified in patients with renal disease.

Geriatric Patients Pharmacokinetic studies in elderly volunteers (61–79 years) and younger adults (18– 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, the average elimination half-life is increased to approximately 4.0 hours (range 3.4–5.1 h) in the elderly compared to 3.2 hours (range 2.1 – 4.2 h) in younger adults.

The extent of absorption, however, is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function 1 . Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity.

Microbiology Mechanism of Action Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Resistance Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA.

Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs i…

🧬 Mechanism of Action 24 words ▾

Mechanism of Action Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

📦 How Supplied / Storage and Handling 55 words ▾

HOW SUPPLIED Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes: 150 mg Light Blue and Green Bottles of 100 NDC 59762-3328-1 300 mg Light Blue Bottles of 16 NDC 59762-5010-1 Bottles of 100 NDC 59762-5010-2 Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

📦 Storage and Handling 15 words ▾

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

📋 Description 115 words ▾

DESCRIPTION Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin.

Inactive ingredients: 150 mg – corn starch, FD & C blue no. 1, FD & C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium dioxide; 300 mg – corn starch, FD & C blue no.

1, gelatin, lactose, magnesium stearate, talc, and titanium dioxide. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside monohydrochloride. Chemical Structure

💬 Information for Patients 213 words ▾

Information for Patients Patients should be counseled that antibacterial drugs, including clindamycin HCl, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin HCl is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin HCl or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug.

If this occurs, patients should contact their physician as soon as possible. Advise patients that due to the risk of esophagitis and esophageal ulcer, it is important to adhere to the administration guidance for clindamycin hydrochloride capsules (see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS ).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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