Cleocin Hydrochloride

Product NDC
0009-0331
11-digit product format
000090331
Labeler code
0009
Product ID
0009-0331_51cea3cd-28cf-455e-ba27-5a0d8e052858
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
75 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 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050162-002CLEOCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050162-003CLEOCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALABRLD, RS1988-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050162-001CLEOCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRLD, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050162-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050162-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050162-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050162-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050162-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050162-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T20OQ1YN1WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197518Internal RxNorm lookup
284215Internal RxNorm lookup
309329Internal RxNorm lookup
748746Internal RxNorm lookup
748748Internal RxNorm lookup
748750Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
df9a2a41-b132-4f43-8940-b2d773b1369aAvailable on FDA.report

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
0009-0331-02Cleocin Hydrochloride100 in 1 BOTTLECAPSULE10040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0331-02EA - Each0009-03311799c0c1-6424-4b53-abc4-229a8999afe412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0331CLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PHARMACIA & UPJOHN COMPANY LLC]37Current NDC, Legacy NDC, 1 package rows20240906_df9a2a41-b132-4f43-8940-b2d773b1369a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEMylan Pharmaceuticals Inc.24595bb3-07ea-4d5f-9bb3-2c2332a1fc622026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050162
application number: NDA050162
Cleocin HydrochlorideCLINDAMYCIN HYDROCHLORIDEPharmacia & Upjohn Company LLCdf9a2a41-b132-4f43-8940-b2d773b1369a2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050162
application number: NDA050162
ndc (product): 0009-0331

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0331-0200009033102100 CAPSULE in 1 BOTTLE (0009-0331-02) 100 capsule1970-05-220000-00-00NoNoCurrent