Clindamycin Phosphate 10 mg/g Gel — NDC 68462-866-35 (Billing 68462-0866-35)
This is a package of Clindamycin Phosphate 10 mg/g Gel from GLENMARK PHARMACEUTICALS INC., USA, marketed since Feb 2021 and currently FDA-listed; retail pharmacies pay about $0.1424 per g (NADAC).
Other active recalls for Clindamycin Phosphate (different manufacturers) — 6 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007726
- GCN: 45410
- GPI-14 (Medi-Span): 90051010104007
- HICL (First Databank): 004045
- AHFS class code: 08:12.28.20
- RxCUI (RxNorm): 2676585
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria that cause acne and by decreasing swelling.
Read the full MedlinePlus article ↗- 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?
Patient education
Supplement & herbal interactions
Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.142 | $4.27 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4916 | $14.75 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3596 | $10.79 / 30 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68462-0866-35 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.1424 / g | $4.27 | 2021-02-10 | — | Active |
| 68462-0866-65 68462-866-65 Main listing | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $0.1307 / g | $7.84 | 2021-02-10 | — | Active |
Per g, this pack runs about 9% above the cheapest pack (NDC 68462-0866-65, $0.1307 vs $0.1424 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 50% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Clindamycin Phosphate 10 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| clindamycin phosphate 10 mg/g 00168-0202-30 | E. | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 16714-0161-01 | NORTHSTAR | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 21922-0027-05 | Encube | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 45802-0900-94 | Padagis | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 51672-1399-02 | Sun | 1 tube | $0.142 | AB1 | Availability likely | — |
| clindamycin phosphate 10 mg/g 59762-3743-01 | Mylan | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 62332-0623-30 | Alembic | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/gthis 68462-0866-35 | GLENMARK | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 72578-0118-01 | Viona | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 73473-0300-30 | Solaris | 1 tube | $0.142 | AB1 | Availability likely | — |
| Clindamycin Phosphate 10 mg/g 46708-0623-30 | Alembic | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 50090-5958-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 50090-6072-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 59651-0806-30 | Aurobindo | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 63629-8630-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 63629-8631-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 63629-9309-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 68788-8423-06 | Preferred | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 70771-1855-02 | Zydus | 1 tube | — | AB1 | FDA listed | — |
| Clindamycin Phosphate 10 mg/g 72162-1436-06 | Bryant | 1 tube | — | AB1 | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Sep 3, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 344S277G0Z
Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
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UNII HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin phosphate gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin film of, clindamycin phosphate gel USP 1% twice daily to affected area. Preserve in tightly closed containers.
⛔ Contraindications ▾
CONTRAINDICATIONS Clindamycin phosphate gel is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
⚠️ Warnings ▾
WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in systemic absorption from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic- associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis.
Stool culture for Clostridioides difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.
Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridioides difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.
Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Number of Patients Reporting Events Treatment Emergent Adverse Event Solution n=553(%) Gel n=148(%) Lotion n=160(%) Burning 62 (11) 15 (10) 17 (11) Itching 36 ( 7) 15 (10) 17 (11) Burning/Itching 60 (11) # ( – ) # ( – ) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 ( 7) 22 (14) Oiliness/Oily Skin 8 ( 1) 26 (18) 12* (10) Peeling 61 (11) # ( – ) 11 ( 7) # not recorded * of 126 subjects Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.
Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ). Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.
🔄 Drug Interactions ▾
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.
🤰 Pregnancy ▾
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. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies for clindamycin phosphate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0 to 3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.
Microbiology Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Antimicrobial Activity Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.
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 in some isolates of macrolide-resistant bacteria.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clindamycin phosphate gel USP, 1% containing clindamycin phosphate, USP equivalent to 10 mg clindamycin per gram is available in the following sizes: 60 gram tube—NDC 68462-866-65 30 gram tube—NDC 68462-866-35 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Rx only Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions?
1 (888) 721-7115 www.glenmarkpharma-us.com Revised: December 2025 logo
📋 Description ▾
DESCRIPTION Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains allantoin, carbomer homopolymer type B, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.
The structural formula is represented below: Molecular formula: C 18 H 34 ClN 2 O 8 PS Molecular weight: 504.96 g/mol The chemical name for clindamycin phosphate, USP 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 2-(dihydrogen phosphate). Clindamycin phosphate, USP is white to off-white, hygroscopic, crystalline powder. Clindamycin phosphate is freely soluble in water, slightly soluble in dehydrated ethanol, very slightly soluble in acetone, insoluble in chloroform, ether and benzene. structure
⚠️ Precautions ▾
PRECAUTIONS General Clindamycin phosphate should be prescribed with caution in atopic individuals. 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.
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. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.
Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora.
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. Clinical Considerations If used during lactation and clindamycin phosphate is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies for clindamycin phosphate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora.
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. Clinical Considerations If used during lactation and clindamycin phosphate is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL carton