Cleocin Hydrochloride

Product NDC
0009-0395
11-digit product format
000090395
Labeler code
0009
Product ID
0009-0395_3cdb1eb4-26cd-495d-b9d2-0ad980fadc2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA050162
Marketing category
NDA
Marketing start
1970-05-22
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050162-001CLEOCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982
N050162-002CLEOCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982
N050162-003CLEOCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N050162-001AB
N050162-002AB
N050162-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-1484e616aacf4f…
2026-08-18 06:07:402026-07N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N050162-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N050162-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N050162-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N050162-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N050162-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N050162-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050162-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050162-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050162-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050162-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050162-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050162-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050162-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050162-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050162-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050162-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050162-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050162-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050162-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050162-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050162-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050162-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050162-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050162-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050162-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050162-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050162-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050162-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050162-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050162-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050162-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050162-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050162-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050162-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050162-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050162-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050162-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050162-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050162-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050162-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cleocin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE300 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0395-14Cleocin Hydrochloride100 in 1 BOTTLECAPSULE10040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0395-14EA - Each0009-039514cd0fb7-e3f6-49c1-b60f-1e355caa94b312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0395CLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PHARMACIA & UPJOHN COMPANY LLC]37Current NDC, Legacy NDC, 1 package rows20240906_df9a2a41-b132-4f43-8940-b2d773b1369a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
748746Cleocin HCl 150 MG Oral CapsulePSNdf9a2a41-b132-4f43-8940-b2d773b1369a40
748748Cleocin HCl 300 MG Oral CapsulePSNdf9a2a41-b132-4f43-8940-b2d773b1369a40
748750Cleocin HCl 75 MG Oral CapsulePSNdf9a2a41-b132-4f43-8940-b2d773b1369a40
197518clindamycin HCl 150 MG Oral CapsulePSNdf9a2a41-b132-4f43-8940-b2d773b1369a40
284215clindamycin HCl 300 MG Oral CapsulePSNdf9a2a41-b132-4f43-8940-b2d773b1369a40
309329clindamycin HCl 75 MG Oral CapsulePSNdf9a2a41-b132-4f43-8940-b2d773b1369a40
748746clindamycin 150 MG Oral Capsule [Cleocin]SBDdf9a2a41-b132-4f43-8940-b2d773b1369a40
748748clindamycin 300 MG Oral Capsule [Cleocin]SBDdf9a2a41-b132-4f43-8940-b2d773b1369a40
748750clindamycin 75 MG Oral Capsule [Cleocin]SBDdf9a2a41-b132-4f43-8940-b2d773b1369a40
197518clindamycin 150 MG Oral CapsuleSCDdf9a2a41-b132-4f43-8940-b2d773b1369a40
284215clindamycin 300 MG Oral CapsuleSCDdf9a2a41-b132-4f43-8940-b2d773b1369a40
309329clindamycin 75 MG Oral CapsuleSCDdf9a2a41-b132-4f43-8940-b2d773b1369a40
748748Cleocin (as clindamycin HCl) 300 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
748750Cleocin (as clindamycin HCl) 75 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
748746Cleocin (as clindamycin phosphate) 150 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
748746Cleocin 150 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
748748Cleocin 300 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
748750Cleocin 75 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
309329clindamycin (as clindamycin hydrochloride) 75 MG Oral CapsuleSYdf9a2a41-b132-4f43-8940-b2d773b1369a40
748748Cleocin HCl 300 MG Oral CapsulePSNb33736bc-5b25-1778-e053-2a95a90a714a3
284215clindamycin HCl 300 MG Oral CapsulePSNb33736bc-5b25-1778-e053-2a95a90a714a3
748748clindamycin 300 MG Oral Capsule [Cleocin]SBDb33736bc-5b25-1778-e053-2a95a90a714a3
284215clindamycin 300 MG Oral CapsuleSCDb33736bc-5b25-1778-e053-2a95a90a714a3
748748Cleocin (as clindamycin HCl) 300 MG Oral CapsuleSYb33736bc-5b25-1778-e053-2a95a90a714a3
748748Cleocin 300 MG Oral CapsuleSYb33736bc-5b25-1778-e053-2a95a90a714a3
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYb33736bc-5b25-1778-e053-2a95a90a714a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0395-1400009039514100 CAPSULE in 1 BOTTLE (0009-0395-14) 100 capsule1970-05-220000-00-00NoNoCurrent