FDA.reportPublic FDA data

Clindamycin hydrochloride

Product NDC
71335-0200
11-digit product format
713350200
Labeler code
71335
Product ID
71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065061
Marketing category
ANDA
Marketing start
2001-03-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui197518

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
71335-0200-02024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-12024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-22024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-32024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-42024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-52024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-62024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-72024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-82024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-92024-09-11C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-02024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-12024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-22024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-32024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-42024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-52024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-62024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-72024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-82024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
71335-0200-92024-01-30C16284748780-11030e365-49b6-111a-e063-dadaa90a10e2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0200-0Clindamycin hydrochloride40 in 1 BOTTLECAPSULE408
71335-0200-1Clindamycin hydrochloride12 in 1 BOTTLECAPSULE128
71335-0200-2Clindamycin hydrochloride28 in 1 BOTTLECAPSULE288
71335-0200-3Clindamycin hydrochloride42 in 1 BOTTLECAPSULE428
71335-0200-4Clindamycin hydrochloride60 in 1 BOTTLECAPSULE608
71335-0200-5Clindamycin hydrochloride30 in 1 BOTTLECAPSULE308
71335-0200-6Clindamycin hydrochloride21 in 1 BOTTLECAPSULE218
71335-0200-7Clindamycin hydrochloride4 in 1 BOTTLECAPSULE48
71335-0200-8Clindamycin hydrochloride56 in 1 BOTTLECAPSULE568
71335-0200-9Clindamycin hydrochloride20 in 1 BOTTLECAPSULE208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0200-0EA - Each71335-0200352a5964-f2d2-4d9e-bf45-ce7433bcad1c12018-03-08
71335-0200-1EA - Each71335-0200ffba4387-41e5-470f-a9d6-105d66a98dda12018-03-08
71335-0200-2EA - Each71335-0200f2ffef27-96b3-4de0-8251-feb20c6cd0cc12018-03-08
71335-0200-3EA - Each71335-0200cd8c1d60-f09c-4158-8d55-8fd7be42a85212018-03-08
71335-0200-4EA - Each71335-0200a2adf60d-4f41-4cd3-be3b-daa2cdab5a3612018-03-08
71335-0200-5EA - Each71335-02006d3ed68f-6db8-4b83-8739-6f447e1f0da412018-03-08
71335-0200-6EA - Each71335-020040f64024-b70f-4934-924c-74c0cb69249512018-03-08
71335-0200-7EA - Each71335-0200f41a3da8-6a14-42b8-af9d-e1455c20ba7412018-03-08
71335-0200-8EA - Each71335-020033aba2f2-4ce5-4f71-a8c0-37c602e70bce12018-03-08
71335-0200-9EA - Each71335-0200614d0d84-08e3-4bdd-92a6-b5a414249eea12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0200CLINDAMYCIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240913_7537fbab-c792-4b77-8736-c24b69cf48ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN7537fbab-c792-4b77-8736-c24b69cf48ea8
197518clindamycin 150 MG Oral CapsuleSCD7537fbab-c792-4b77-8736-c24b69cf48ea8
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY7537fbab-c792-4b77-8736-c24b69cf48ea8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0200-07133502000040 CAPSULE in 1 BOTTLE (71335-0200-0) 40 capsule2018-02-260000-00-00NoNoCurrent
71335-0200-17133502000112 CAPSULE in 1 BOTTLE (71335-0200-1) 12 capsule2019-04-220000-00-00NoNoCurrent
71335-0200-27133502000228 CAPSULE in 1 BOTTLE (71335-0200-2) 28 capsule2018-02-130000-00-00NoNoCurrent
71335-0200-37133502000342 CAPSULE in 1 BOTTLE (71335-0200-3) 42 capsule2018-10-160000-00-00NoNoCurrent
71335-0200-47133502000460 CAPSULE in 1 BOTTLE (71335-0200-4) 60 capsule2018-03-020000-00-00NoNoCurrent
71335-0200-57133502000530 CAPSULE in 1 BOTTLE (71335-0200-5) 30 capsule2018-03-200000-00-00NoNoCurrent
71335-0200-67133502000621 CAPSULE in 1 BOTTLE (71335-0200-6) 21 capsule2019-04-020000-00-00NoNoCurrent
71335-0200-7713350200074 CAPSULE in 1 BOTTLE (71335-0200-7) 4 capsule2024-09-050000-00-00NoNoCurrent
71335-0200-87133502000856 CAPSULE in 1 BOTTLE (71335-0200-8) 56 capsule2024-09-050000-00-00NoNoCurrent
71335-0200-97133502000920 CAPSULE in 1 BOTTLE (71335-0200-9) 20 capsule2018-03-230000-00-00NoNoCurrent