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Clindamycin Hydrochloride 300 mg Capsule, 30-count — NDC 50090-3907-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clindamycin Hydrochloride 300 mg Capsule, 30-count — NDC 50090-3907-0 (Billing 50090-3907-00)

by A-S Medication Solutions · 30 CAPSULE in 1 BOTTLE

This is a package of 30 capsules of Clindamycin Hydrochloride 300 mg Capsule from A-S Medication Solutions, marketed since Aug 2009 and currently FDA-listed. It is the main listing for this product, which comes in 6 package sizes.

NDC 50090-3907-00
🏷️ FDA NDC (as labeled) 50090-3907-0 billing pads the package segment with a zero
This package
Contains30-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.1397/unit — full pricing hub ↓
Main listing for product 50090-3907 · Also comes in: 3 capsules 50090-3907-5 16 capsules 50090-3907-2 20 capsules 50090-3907-4 40 capsules 50090-3907-3 45 capsules 50090-3907-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-3907-0
Product NDC 50090-3907
11-digit billing NDC 50090390700
NCPDP billing unit EA — each (per item)
RxCUI 284215
UNII T20OQ1YN1W
Application # ANDA065442
SPL Set ID 2393251d-33b9-4274-9d04-27ec9968eaa1
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-08-26
Route ORAL
Dosage form CAPSULE
Substance CLINDAMYCIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

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
Quick answers
  • GSN (GCN sequence number): 009340
  • GCN: 40832
  • HICL (First Databank): 004044
  • AHFS class code: 08:12.28.20
  • RxCUI (RxNorm): 284215
Why two NDCs? The FDA registers this code as 50090-3907-0 — 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 → 50090-3907-00. 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.

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
  • It treats serious bacterial infections, such as anaerobic infections, skin, lung, abdominal, gynecological, and bone and joint infections, depending on the product. It is often use...
  • Swallow them with a full glass of water and stay upright for at least 30 minutes afterward. This helps prevent irritation of your throat. Take it as often as your prescriber says a...
  • Rash, nausea, vomiting, stomach pain and itching are among the more commonly reported effects. Call your doctor right away if you get severe, watery or bloody diarrhea, even weeks...
  • What side effects are normal, and when should I call you?
📖 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.

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 · Q2 2026 $0.1397 $4.19 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-3907-00 You're viewing this Main listing 30 CAPSULE in 1 BOTTLE 2018-12-05 — Active
50090-3907-01 50090-3907-1 45 CAPSULE in 1 BOTTLE 2018-12-05 — Active
50090-3907-02 50090-3907-2 16 CAPSULE in 1 BOTTLE 2018-12-05 — Active
50090-3907-03 50090-3907-3 40 CAPSULE in 1 BOTTLE 2018-12-05 — Active
50090-3907-04 50090-3907-4 20 CAPSULE in 1 BOTTLE 2018-12-05 — Active
50090-3907-05 50090-3907-5 3 CAPSULE in 1 BOTTLE 2024-05-14 — Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 capsule in 1 bottle.
How does this package differ from NDC 50090-3907-05?
Both are Clindamycin Hydrochloride 300 mg Capsule — the drug itself is identical. This page's package is the 30-count one, while NDC 50090-3907-05 is the 3 capsules package.
What NDC number is used to bill for this package of Clindamycin Hydrochloride 300 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin Hydrochloride 300 mg 00904-7194-61 Major 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 42571-0252-01 Micro 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 50268-0185-15 AvPAK 50 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 62135-0766-01 Chartwell 100 capsules $0.175 — Availability likely —
Clindamycin hydrochloride 300 mg 63304-0693-01 Sun 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 65862-0186-01 Aurobindo 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 68084-0244-01 American 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 68462-0144-01 GLENMARK 100 capsules $0.175 AB Availability likely —
clindamycin hydrochloride 300 mg 59762-5010-01 Mylan 16 capsules $0.176 AB Discontinued —
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 mgthis 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 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

🏛️
2009
On the market since
Aug 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA065442 (ANDA)
Labeler code50090
First marketedAug 2009
Product typeHuman Prescription Drug
Portfolio2,811 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 215 words ▾

WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride 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 hydrochloride 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued.

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

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules are 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 hydrochloride and other antibacterial drugs, clindamycin hydrochloride 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 201 words ▾

DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING ). Adults: Serious infections - 150 to 300 mg every 6 hours. More severe infections - 300 to 450 mg every 6 hours.

Pediatric Patients (for children 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.

To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water. Clindamycin hydrochloride capsules are not suitable for children 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 clindamycin injection. However, in clinically appropriate circum­stances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules. In cases of β-hemolytic streptococcal infections, treat­ment should continue for at least 10 days.

⛔ Contraindications 19 words ▾

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

⚠️ Warnings ~1 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 hydrochloride, 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic 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 severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and 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 hydrochloride 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, esophagitis, nausea, vomiting, and diarrhea (see BOXED WARNING ). The onset of pseudomembranous coli­tis symptoms may occur during or after antibacterial treatment (see WARNINGS ).

Esophageal ulcer has been reported. 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 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 101 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 antibiotic-associated colitis and diarrhea (due to Clostridioides difficile ) seen in association with most anti­biotics 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 2.5 mcg/mL was reached in 45 minutes; serum concentrations averaged 1.51 mcg/mL at 3 hours and 0.7 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 to 79 years) and younger adults (18 to 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 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours (range 2.1 to 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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Product: 50090-3907 NDC: 50090-3907-0 30 CAPSULE in a BOTTLE NDC: 50090-3907-1 45 CAPSULE in a BOTTLE NDC: 50090-3907-2 16 CAPSULE in a BOTTLE NDC: 50090-3907-3 40 CAPSULE in a BOTTLE NDC: 50090-3907-4 20 CAPSULE in a BOTTLE NDC: 50090-3907-5 3 CAPSULE in a BOTTLE

📋 Description 125 words ▾

DESCRIPTION Clindamycin hydrochloride is the hydrated hydrochlo­ride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. 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.

The structural formula is represented below: Clindamycin hydrochloride capsules, USP contain clindamycin hydro­chloride USP equivalent to 150 mg or 300 mg of clindamycin. Each capsule also contains the following inactive ingredients: lactose monohydrate, corn starch, talc, and magnesium stearate. The empty hard gelatin capsule shell consists of FD&C Blue #1, titanium dioxide, gelatin, and sodium lauryl sulphate.

In addition 150 mg also contains yellow iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac. Chemical Structure

💬 Information for Patients 176 words ▾

Information for Patients Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin hydrochloride 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 hydrochloride or other antibacte­rial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic.

If this occurs, patients should contact their physician as soon as possible.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Review of experience to date suggests that a sub­group of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency. Clindamycin hydrochloride should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin hydrochloride should be prescribed with caution in atopic individuals. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. The use of clindamycin hydrochloride occasionally results in over­growth of nonsusceptible organisms—particularly yeasts.

Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. Clindamycin dosage modification is not necessary in patients with renal disease. In patients with mod­erate to severe liver disease, prolongation of clindamycin half-life has been found.

However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme deter­minations should be made when treating patients with severe liver disease.

Prescribing clindamycin hydrochloride in the absence of a proven or strongly suspected bacterial infection or a prophylac­tic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resis­tant bacteria. Information for Patients Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When clindamycin hydrochloride 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 hydrochloride or other antibacte­rial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible. Laboratory Tests During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

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. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been per­formed with clindamycin to evaluate carcinogenic poten­tial. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion tes… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 132 words ▾

Nursing Mothers Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.

Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 70 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been per­formed with clindamycin to evaluate carcinogenic poten­tial. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest rec­ommended adult human dose based on mg/m 2 ) revealed no effects on fertility or mating ability.

📚 References 52 words ▾

REFERENCES Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982. Trademarks are the property of their respective owners. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 07/2022

📄 Package Label / Principal Display Panel 4 words ▾

Clindamycin Hydrochloride Label Image

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

About this NDC listing & data coverage

Finished prescription product
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Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
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Questions about this listing

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
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Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 3 capsules (50090-3907-05), 16 capsules (50090-3907-02), 20 capsules (50090-3907-04). Each has its own NDC and its own page — see the package list near the top of this page.
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A-S Medication Solutions 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.
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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.
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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.
← 50090-3905-00 · A-S 50090-3914-00 · A-S →
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