Cleocin Hydrochloride

Product NDC
67296-1798
Requested package NDC
67296-1798-3
11-digit product format
672961798
Labeler code
67296
Product ID
67296-1798_d61cbe73-007a-6e07-e053-2a95a90a1386
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA050162
Marketing category
NDA
Marketing start
1970-05-22
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-179867296-1798-3IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1798-32024-07-25C16284748780-11030e365-61cf-111a-e063-dadaa90a10e2CLEOCIN HCl 300MG
67296-1798-32024-01-30C16284748780-11030e365-61cf-111a-e063-dadaa90a10e2CLEOCIN HCl 300MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1798-3Cleocin Hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1798CLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20240727_b33736bc-5b25-1778-e053-2a95a90a714a.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
67296-1798-36729617980330 CAPSULE in 1 BOTTLE (67296-1798-3) 30 capsule1970-05-220000-00-00NoNoCurrent