Clindamycin Hydrochloride

Product NDC
71335-1581
Requested package NDC
71335-1581-2
11-digit product format
713351581
Labeler code
71335
Product ID
71335-1581_f3d2a420-5d42-478a-a0a2-d6fbf1373e19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065243
Marketing category
ANDA
Marketing start
2005-08-12
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-158171335-1581-2DDiscontinued by firm2026-08-03
excluded packagepackage71335-158171335-1581-2DDiscontinued by firm2026-08-03

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 · 27 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…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
A065243-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12
A065243-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12
A065243-003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065243-002AB

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 UTC2026-02A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065243-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065243-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065243-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065243-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065243-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065243-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065243-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065243-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065243-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065243-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065243-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065243-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065243-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065243-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065243-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065243-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065243-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065243-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065243-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065243-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065243-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065243-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065243-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065243-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065243-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065243-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065243-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065243-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065243-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065243-002AB16a51e52b5d6a…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1581-0Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE40100
71335-1581-1Clindamycin Hydrochloride12 in 1 BOTTLECAPSULE12100
71335-1581-2Clindamycin Hydrochloride28 in 1 BOTTLECAPSULE28100
71335-1581-3Clindamycin Hydrochloride42 in 1 BOTTLECAPSULE42100
71335-1581-4Clindamycin Hydrochloride60 in 1 BOTTLECAPSULE60100
71335-1581-5Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE30100
71335-1581-6Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE21100
71335-1581-7Clindamycin Hydrochloride4 in 1 BOTTLECAPSULE4100
71335-1581-8Clindamycin Hydrochloride56 in 1 BOTTLECAPSULE56100
71335-1581-9Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE20100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1581CLINDAMYCIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Legacy NDC, 10 package rows20220211_ac73750d-898e-4c91-b4ba-7d8ff6636244.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEChartwell RX, LLCe8167412-882e-4143-93c6-49e68adbcf162024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065243
application number: ANDA065243

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNac73750d-898e-4c91-b4ba-7d8ff6636244100
197518clindamycin 150 MG Oral CapsuleSCDac73750d-898e-4c91-b4ba-7d8ff6636244100
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYac73750d-898e-4c91-b4ba-7d8ff6636244100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1581-27133515810228 CAPSULE in 1 BOTTLE (71335-1581-2) 28 capsule2022-02-100000-00-00NoNoCurrent