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Cleocin Hydrochloride

clindamycin hydrochloride · Capsule

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Cleocin Hydrochloride
Generic name
clindamycin hydrochloride
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Pharmacia & Upjohn Company LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Clindamycin Hydrochloride 150 mg/1 197518 View
Clindamycin Hydrochloride 300 mg/1 197518 View
Clindamycin Hydrochloride 75 mg/1 197518 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Sebaceous Gland Activity [PE] PE All 37 members
Lincosamide Antibacterial [EPC] EPC All 19 members
Lincosamides [CS] CS All 19 members
Neuromuscular Blockade [PE] PE All 24 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
050162
Application type
NDA · New Drug Application
Approval date
February 22, 1970
Sponsor
PFIZER
Products on application
3
Submissions recorded
91
Products approved under application 050162.
Product Trade name Form Strength Ingredient Status TE Flags
050162-001 CLEOCIN HYDROCHLORIDE CAPSULE CLINDAMYCIN HYDROCHLORIDE Prescription AB RLD
050162-002 CLEOCIN HYDROCHLORIDE CAPSULE CLINDAMYCIN HYDROCHLORIDE Prescription AB RLD
050162-003 CLEOCIN HYDROCHLORIDE CAPSULE CLINDAMYCIN HYDROCHLORIDE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 050162.
Type No. Action Status Date Review
Supplement 108 Labeling Approved September 1, 2026 Standard
Supplement 107 Labeling Approved March 26, 2026 Standard
Supplement 106 Labeling Approved February 12, 2026 Standard
Supplement 105 Labeling Approved July 29, 2024 Standard
Supplement 104 Labeling Approved May 20, 2022 Standard
Supplement 102 Labeling Approved March 9, 2020 Standard
Supplement 101 Labeling Approved June 13, 2019 Standard
Supplement 100 Labeling Approved March 15, 2018 Standard
Supplement 99 Labeling Approved May 2, 2017 Standard
Supplement 98 Labeling Approved May 2, 2017 Standard
Supplement 97 Labeling Approved August 2, 2016 Standard
Supplement 96 Labeling Approved March 23, 2016 Standard
Supplement 95 Labeling Approved March 23, 2016 Standard
Supplement 94 Manufacturing (CMC) Approved January 21, 2016 —
Supplement 93 Labeling Approved June 26, 2014 Standard
Supplement 92 Labeling Approved June 26, 2014 Standard
Supplement 90 Labeling Approved June 7, 2011 Unknown
Supplement 85 Labeling Approved November 20, 2009 Standard
Supplement 82 Labeling Approved September 29, 2004 Standard
Supplement 84 Labeling Approved January 28, 2004 Standard
Supplement 83 Manufacturing (CMC) Approved November 15, 1999 —
Supplement 81 Manufacturing (CMC) Approved February 24, 1998 —
Supplement 80 Labeling Approved December 12, 1997 Standard
Supplement 79 Labeling Approved July 17, 1997 Standard
Supplement 22 Labeling Approved March 17, 1997 —
Supplement 18 Labeling Approved March 17, 1997 —
Supplement 9 Labeling Approved March 17, 1997 —
Supplement 20 Labeling Approved February 21, 1995 —
Supplement 21 Manufacturing (CMC) Approved March 5, 1993 —
Supplement 11 Efficacy Approved April 14, 1988 —
Supplement 10 Labeling Approved October 20, 1986 —
Supplement 5 Labeling Approved September 10, 1985 —
Supplement 7 Labeling Approved June 21, 1985 —
Supplement 4 Manufacturing (CMC) Approved April 29, 1983 —
Supplement 77 Manufacturing (CMC) Approved April 27, 1982 —
Supplement 76 Efficacy Approved November 3, 1981 —
Supplement 75 Manufacturing (CMC) Approved May 20, 1981 —
Supplement 74 Manufacturing (CMC) Approved May 27, 1980 —
Supplement 73 Labeling Approved April 30, 1980 —
Supplement 72 Labeling Approved November 6, 1979 —
Supplement 71 Manufacturing (CMC) Approved July 20, 1979 —
Supplement 70 Labeling Approved July 9, 1979 —
Supplement 69 Labeling Approved July 9, 1979 —
Supplement 64 Labeling Approved June 28, 1979 —
Supplement 68 Manufacturing (CMC) Approved May 18, 1979 —
Supplement 67 Labeling Approved April 24, 1979 —
Supplement 66 Labeling Approved October 4, 1978 —
Supplement 63 Labeling Approved July 11, 1978 —
Supplement 62 Manufacturing (CMC) Approved February 14, 1978 —
Supplement 57 Labeling Approved August 15, 1977 —
Supplement 61 Labeling Approved January 3, 1977 —
Supplement 60 Manufacturing (CMC) Approved July 2, 1976 —
Supplement 59 Manufacturing (CMC) Approved June 2, 1976 —
Supplement 58 Manufacturing (CMC) Approved January 28, 1976 —
Supplement 56 Labeling Approved November 17, 1975 —
Supplement 55 Labeling Approved June 11, 1975 —
Supplement 54 Labeling Approved March 17, 1975 —
Supplement 53 Labeling Approved March 14, 1975 —
Supplement 50 Labeling Approved August 16, 1974 —
Supplement 52 Labeling Approved August 9, 1974 —

Review documents

  • 0 · Supplement · September 8, 2026
  • 0 · Supplement · September 2, 2026
  • 0 · Supplement · March 30, 2026
  • 0 · Supplement · March 30, 2026
  • 0 · Supplement · February 19, 2026
  • 0 · Supplement · February 13, 2026
  • 0 · Supplement · July 30, 2024
  • 0 · Supplement · July 30, 2024
  • 0 · Supplement · May 27, 2022
  • 0 · Supplement · May 23, 2022
  • 0 · Supplement · March 10, 2020
  • 0 · Supplement · March 10, 2020
  • 0 · Supplement · June 17, 2019
  • 0 · Supplement · June 14, 2019
  • 0 · Supplement · March 20, 2018
  • 0 · Supplement · March 16, 2018
  • 0 · Supplement · May 8, 2017
  • 0 · Supplement · May 8, 2017
  • 0 · Supplement · May 4, 2017
  • 0 · Supplement · May 4, 2017
  • 0 · Supplement · March 29, 2016
  • 0 · Supplement · March 29, 2016
  • 0 · Supplement · March 25, 2016
  • 0 · Supplement · March 25, 2016
  • 0 · Supplement · June 30, 2014
  • 0 · Supplement · June 30, 2014
  • 0 · Supplement · June 27, 2014
  • 0 · Supplement · June 27, 2014
  • 0 · Supplement · June 10, 2011
  • 0 · Supplement · January 21, 2010

Adverse event reports

Source: openFDA FAERS
3,415
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CLINDAMYCIN HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0009-0225-02 0009-0225 Pharmacia & Upjohn Company LLC 100 CAPSULE in 1 BOTTLE (0009-0225-02) May 22, 1970
0009-0331-02 0009-0331 Pharmacia & Upjohn Company LLC 100 CAPSULE in 1 BOTTLE (0009-0331-02) May 22, 1970
0009-0395-14 0009-0395 Pharmacia & Upjohn Company LLC 100 CAPSULE in 1 BOTTLE (0009-0395-14) May 22, 1970
0009-0225 0009-0225 Pharmacia & Upjohn Company LLC — May 22, 1970
0009-0331 0009-0331 Pharmacia & Upjohn Company LLC — May 22, 1970
0009-0395 0009-0395 Pharmacia & Upjohn Company LLC — May 22, 1970

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.